Quality Specialist Salary in California, USA

About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website - http://www.hcltech.comMinimum QualificationsBS degree in relevant discipline (Mechanical or Biomedical science engineering) with years of experience in product design Regulatory requirementCertification such as RAC (Regulatory Affairs Certification) is often preferredPreferred QualificationsQuality or Regulatory compliance experienceExperience with product lifecycle management, premarket and post-market product line support.Strong understanding and wide application of technical or regulatory principles, theories, and concepts; general knowledge of other related disciplinesGood exposure in Medical Device product development process.Shall work independentlyCompetencies RequiredReview regulatory submissions for new products and product changes as required to ensure timely approval for clinical studies and product market release.Review significant regulatory strategies with leadership team, as necessary..Provide on-going support to core and project teams for regulatory issues and questions. Investigate, interpret and apply regulations and guidance appropriately for situations.Review business and product information to RA Leadership to enable development of strategies and requirements to communicate information to leadership team.Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.Work with RA Leadership and other members of the RA team to help support discussions with FDA or other regulatory agencies, as needed.Significant changes will be reviewed with the RA Leadership.Maintain Regulatory Affairs product files to support compliance with regulatory requirements.Interact frequently with different members of the organization and outside customers.Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.Review training, promotional and advertising pieces for assigned product lines.Provide training and support to other members of the organization.Support Quality Systems Projects as required.Adhere to all company policies, procedures, and business ethics codes.Duties may be modified or assigned at any time based on business need.Required Knowledge, SkillsAbility to provide solutions to a wide range of difficult problems.Solutions are imaginative, thorough, practical, and consistent with organizational objectives.Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions.Strong organizational, time management and project management skillsStrong knowledge of Microsoft OfficeEffective presentation and interpersonal skillsSelf-motivationExcellent verbal/written communication skillsStrong attention to detail and accuracyAbility to communicate persuasively in a manner that supports approvals and other key company goals/objectives.Able to work effectively both independently and in a collaborative team environment

Food Quality Specialist Bilingual KoreanLos Angeles, CaliforniaKorean/English bilingual is a must.Strong Understanding of food product development and import/export process.Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for youCompensationBase Salary and Full BenefitsJob Requirements and DutiesBachelor's degree, preferably in Food Science, Nutrition, or a related fieldKnowledge of FDA/USDA food regulations and documentation requirements.Daily review and approval of production and quality documentation to ensure all data submitted is complete and accurateEnsure audit readiness for all Internal Quality Audits and all other 3rd Party audits such as Organic, FDA, etc, and respond to findings with Preventive and Corrective ActionsLead the execution of cultural changes andactivities needed to support Continuous Improvement and QA&FS InitiativesInterpret quality control philosophy to key personnel within companyProvide, and oversee, inspection activity for product throughout production cycleApply total quality management tools and approaches to analytical and reporting processesSchedule and coordinate preparations for product inspections and testingAssist in Quality Assurance projects for production auditingWork to resolve noncompliance issues with materials or final productsEnsuring and maintaining the calibration of all equipment and instrumentsPreparing and periodically reviewing all QC SOPsEnsure safe work practices for the Quality Control LaboratoryJasleen [email protected] Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.#ZR

Quality Control SpecialistUS-CA-IrvineJob ID: 2024-12150Type: Employee# of Openings: 1Category: Quality Control and VBLSSUS-CA-Irvine-2851OverviewThis role is responsible for performing inspection tasks related to in-process, Final and/or Receiving Inspection areas.ResponsibilitiesPerform Inspection on all products within a timely mannerDetermine product conformance or non-conformance to drawingsUse SAP to transact product to inventory or to MRBWrite non-conformances for product that is not acceptable to requirementsDetailed review of product against requirementsDocument results in Excel and SAPSafety is a core value at ITT. Our employees understand and follow all ITT safety policies and procedures, participate in workplace inspections, safety training, and in the development of job safety analyses.QualificationsHigh School Diploma or GED required, with 3 years of technical industry experience in a manufacturing environmentThis position requires US Citizenship due to the visibility of NO FORN projectsWorking knowledge of use of measuring equipment – calipers, micrometer optical measurement equipmentBlueprint reading with GD&T, test specificationsSAP or equivalent ERP system knowledgeProficiency in MS Excel, OutlookAble to speak, read, and understand English; clear verbal communicationPreferred:Experience in Coordinate Measuring Machine (CMM) use and other inspection related documentation as requiredMust be able to interpret data from CMMMilitary, industry automotive or aerospace standards experience. Spacecraft component and sub-systems experience.Work experience in an organization with AS9100 or ISO 9001 certifiedPI240617412

Description:• Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.• Perform document change control activities as needed.• Perform and lead in investigations, NCMRs and Complaints.• Track and monitor CAPAs.• Perform training as needed.• Support Distribution activities.• Collect quality metrics.• Support the Quality Operations Director with internal, supplier, regulatory and customer audits.• Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor.• Perform QC inspection or release of incoming GMP materials according to appropriate material specifications.• Ensure department and company goals are met.• May perform other department tasks.Skills:CAPA, GMP, NCMR, QA, QC, inspectionQualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Required:High School Diploma and/or 3-5 years related experience and/or training.Basic Mathematical Skills:Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations.Ability to read various types of standard items addressed to general readers.High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.Experience Level:Intermediate LevelAbout ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

Description:• Perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance to GMP and company procedures.• Perform document change control activities as needed.• Perform and lead in investigations, NCMRs and Complaints.• Track and monitor CAPAs.• Perform training as needed.• Support Distribution activities.• Collect quality metrics.• Support the Quality Operations Director with internal, supplier, regulatory and customer audits.• Perform QC line clearances, in-process checks and monitoring of labeling and packaging activities on the floor.• Perform QC inspection or release of incoming GMP materials according to appropriate material specifications.• Ensure department and company goals are met.• May perform other department tasks.Skills:CAPA, GMP, NCMR, QA, QC, inspectionAdditional Skills & Qualifications:Qualifications: High School Diploma and/or 3-5 years related experience and/or training (lead CAPAs, NCMRs, investigations, change control, etc)Basic Mathematical SkillsBasic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations.Ability to read various types of standard items addressed to general readers.High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

DESCRIPTIONThe Loss Prevention Specialist (LPS) is a key hourly associate position within Amazon Operations. The LPS leads the effort to efficiently and effectively oversee security services and asset (lives, buildings, equipment, inventory, data, & intellectual property) protection in a designated building. The LPS reports to the Loss Prevention site lead responsible for their facility, and aids them in supporting the Operational team, and the cross functional teams throughout the organization. The position is site based.Key job responsibilitiesLead, conduct, and deliver results regarding investigations of Theft, Fraud, and Workplace Violence/Critical IncidentsPrepare prompt and complete reports relative to Workplace Violence, Theft, Fraud, Critical Incidents, and Process ImprovementDeliver results through policy Guidance, Education, and Mitigation strategies to help meet business demandsServe as department’s liaison and security/crisis management subject matter expert for site leadership keeping them informed on key issues, strategies and the department’s performanceAnalyze data, conducts audits and identify trends to create actionable plans to mitigate riskMaintain confidentiality in matters involving security and/or personnel issues in the work placeEffectively partner with internal customers in evaluating current and future security services, processes and initiativesDevelop strategies for alarm reduction and conduct system diagnostic for problematic devices by engaging and resolving issues with internal and external partnersAccurately communicate verbally and in written form to a broad customer baseTrain and orient new Associates in LP cultureDevelop projects while continuously improving physical security, processes, standards, training, and policies for future growthEnsure internal controls per Sarbanes Oxley (SOX) requirements related to data center access controls, inventory control and record keepingPromote and execute security best practicesAudit physical security infrastructure (i.e. intrusion detection, access control, cameras) and ensuring functionally of all systems Work weekends and/or overnight shifts as necessaryWork in an industrial environment that requires walking up to 5 miles a day and ability to lift up to 20 lbs, with or without reasonable accommodationA day in the lifeThe primary focus of the Loss Prevention Specialist is to promote safety and be a visible deterrent preventing losses at an Amazon Fresh Store (AFS) location.There is a lot of interaction with community members as well as Amazon Associates / Leadership with a heavy emphasis on preventing losses through customer service and training.About the teamGlobal Security Operations (GSO) is the global organization that supports field Loss Prevention and is designed to support Amazon’s Worldwide Operations, as well as affiliate and retail businesses, by creating and maintaining a work environment that is both prepared and secure through global security centers of excellence staffed by subject matter experts in people and asset protection. We accomplish this by creating policy and implementation guidelines; training leadership and staff; using technology to eliminate subjectivity, complexity, and variation; identifying, preparing for, and mitigating risk; and auditing our practices to ensure compliance.We are open to hiring candidates to work out of one of the following locations:Los Angeles, CA, USABASIC QUALIFICATIONSHigh school or equivalent diploma 1+ years of experience in the following: security service, asset protection, audit, investigations, law enforcement, military, risk management, inventory control, quality assurance or bachelor’s degree in a related field or 2+ years Amazon Experience and/or LPQ Career Choice GraduateExperience with MS Office Professional Suite, including Excel Workplace Violence and/or Business Continuity experience Analytical experience in performance based, action and results oriented settingPREFERRED QUALIFICATIONSDemonstrated ability to work independently with off-site supervision Demonstrated ability to engage with others at all levels Strong oral and written communication skills Comfortable working in a fast-paced and multi-tasking environment1+ year of leadership or management experienceProfessional credentials in Loss Prevention, such as, Wicklander and Zulawski certification Experience with warehouse or distribution center services Experience conducting internal or external interviewsFamiliarity with Lean Six Sigma concepts desired and certificationStrong familiarity with data bases (querying and analyzing) such as SQL, MYSQL, Access, Exception-Based Reporting, etc. Awareness and implementation of best practices related to the utilization of physical security systems, investigation techniques, effective oversight of contract security officers, and distribution center loss mitigation techniquesAmazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit https://www.amazon.jobs/en/disability/us.Pursuant to the Los Angeles Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $31,700/year in our lowest geographic market up to $56,700/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit https://www.aboutamazon.com/workplace/employee-benefits. Applicants should apply via our internal or external career site.

Description:Maintains Investigation, CAPA, Complaints, Change Control systems logs.Leads and reviews investigations (deviations, excursions, complaints). Ensures CAPAs are assigned and followed through.Perform primary quality batch record review. Assists in the preparation for Health Authority inspections and audits and provides support to their execution and follow-up.Review and approval of quality related documents.Assists in collection of data for Annual Product Reviews.Writes Annual Product Reviews.Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results.Monitors Quality Systems and advises Quality Compliance supervisor on system performance; publishes statistics regarding performance against set goals and makes recommendations.Trending of Quality metrics.Performs trainings on various GMP related topics as needed.Skills:Quality Assurance Technician , pharmaceutical, QA, lab techTop Skills Details:Quality Assurance Technician ,pharmaceutical, QA, lab techAdditional Skills & Qualifications:Bachelor's degree in sciences or related field required, Bachelor's degree in Microbiology preferred2-3 years' relevant experience in a regulated Pharmaceutical industry including Quality Systems, Quality Assurance, Quality Control.Knowledge of cGMP, Quality Systems (CAPA, Investigations, Complaints, Change Control), Drug Regulatory Affairs, manufacturing and packaging processes required.Experience Level:Entry LevelAbout ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

Certified Group is a leading North American provider of laboratory testing and audit and certification services. The Certified Group of companies includes Food Safety Net Services (FSNS), Certified Laboratories, EAS Consulting Group, Labstat International Inc. The Certified Group provides analytical testing and regulatory guidance services in the food & beverage, dietary supplements & NHP, cosmetics, OTC, personal care, tobacco, cannabis, nicotine, and hemp industries.We are seeking a highly skilled Quality Assurance Specialist to join our team!In this key role you will work on ensuring compliance with FDA regulations within our industry. The ideal candidate will have extensive experience in managing electronic Quality Management Systems (eQMS), particularly in areas such as Corrective and Preventive Actions (CAPA), Customer Complaints, Out of Specification (OOS) investigations, and conducting Internal Audits. The Quality Assurance Specialist will play a pivotal role in maintaining and improving our quality management processes to uphold the highest standards of product quality and regulatory compliance.RESPONSIBILITIES:• Assist in the implementation, maintenance, and continuous improvement of the electronic Quality Management System (eQMS) to ensure compliance with FDA regulations.• Lead and coordinate Corrective and Preventive Action (CAPA) processes, including investigation, root cause analysis, implementation of corrective actions, and effectiveness checks.• Handle Customer Complaints and Out of Specification (OOS) investigations, ensuring timely resolution and documentation according to regulatory requirements.• Conduct thorough Internal Audits to assess compliance with established quality procedures, identify areas for improvement, and develop corrective actions as needed.• Collaborate with cross-functional teams to provide quality assurance guidance and support throughout all stages of operation.• Develop and maintain quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records, in accordance with FDA regulations.• Assist in the preparation and hosting of regulatory agency inspections and audits, as well as follow-up activities to address any findings or observations.• Stay abreast of regulatory requirements and industry best practices related to quality assurance and quality management systems, and proactively implement necessary changes to ensure compliance.REQUIREMENTS:• Bachelor's degree in a scientific or technical field, such as Chemistry, Biology, Engineering, or related discipline.• 5-10 years of experience in a quality assurance role within an FDA regulated industry, preferably in pharmaceuticals, medical devices, or biotechnology.• Strong understanding of FDA regulations and guidelines, including cGMP, 21 CFR Part 11, and ICH guidelines.• Proven experience in managing electronic Quality Management Systems (eQMS), such as Qualtrax, Intact, or similar platforms.• Proficiency in conducting investigations, root cause analysis, and implementing corrective actions for CAPA, Customer Complaints, and OOS events.• Experience in conducting Internal Audits and familiarity with audit processes and methodologies.• Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate quality requirements to stakeholders at all levels of the organization.• Strong attention to detail and analytical skills, with the ability to analyze complex data sets and identify trends or areas for improvement.• Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.BENEFITS:§ Progressive 401k Retirement Savings Plan§ Employer Paid Short- Term and Long-Term Disability, and Life Insurance§ Group Medical§ Tuition Reimbursement§ Flexible Spending Accounts§ Dental§ Paid Holidays and Time Off§ Many positions which qualify for the company bonus programCertified Group values diversity in its workforce. The company is firmly committed to a policy of Equal Opportunity and will administer its policies in a manner that treats each employee and applicant for employment on the basis of merit. Certified Group will take affirmative action to seek out qualified applicants without regard to race, color, religion, sex, national origin, age, handicap, or veteran status.

Business System Specialist, Expert - Oakland **Location** Oakland, California; I'm Interested (https://careers.pge.com/job/Oakland-Business-System-Specialist%2C-Expert-Oakland-CA-94612/1169850500/?feedId=306700) Requisition ID # 156393 Job Category: Information Technology Job Level: Individual Contributor Business Unit: Electric Engineering Work Type: Hybrid Job Location: Oakland **Position Summary** The Business System Specialist (BSS) functions as a liaison to Information Technology from the line of business, representing the end users and business process owners in business system requirements, implementations and support. The incumbent understands user needs as well as business procedures, processes and systems for the corresponding department. The incumbent typically defines user system requirements, provides user support, coordinates user acceptance testing of new tools and consults with the users on new technologies & features that may contribute to business process efficiencies. The incumbent may also perform feasibility analysis, develop project scope, and provide recommendations on alternative solutions, project strategy and deliverable prioritization. The incumbent prepares and delivers business users’ system needs to Information Technology and represents user needs in the development of functional specifications. This specific position will be responsible to perform, among others, project management activities (scope, schedule, cost) for multiple data quality improvement projects ranging in size from thousands to multi-million dollars as well as collaborating to develop programmatic processes for sustainable execution once projects are completed. Strong Project Management and Process Improvement experience and skills are needed. Experience with GIS and data quality is a plus. This position is hybrid, working from your remote office and Oakland based on business needs. PG&E is providing the salary range that the company in good faith believes it might pay for this position at the time of the job posting. This compensation range is specific to the locality of the job. The actual salary paid to an individual will be based on multiple factors, including, but not limited to, specific skills, education, licenses or certifications, experience, market value, geographic location, and internal equity. Although we estimate the successful candidate hired into this role will be placed towards the middle or entry point of the range, the decision will be made on a case-by-case basis related to these factors.​ A reasonable salary range is:​ Bay Area Minimum: $​118,000 Bay Area Maximum: $​188,000 **Job Responsibilities** + Provide expert consulting in business and user needs + Analyze and document business requirements for complex projects + Position will support risk management, strategy and planning, training, reporting, finance, quality management, and process improvement + Write Standards, Procedures, Job Aids, Bulletins, Manuals, Requests for Change, + Analyze end-to-end complex business processes and coordinate with other stakeholders to develop and implement solutions to information needs + Understand in detail current and future business environment; effectively anticipate, identify, and fully meet the business needs + Identify, propose and influence solutions to complex business problems + Anticipate concerns and questions, and provide proactive, timely and professional communications or delegate as appropriate + Act as a key contributor to teams that define, review and approve requirements for the business needs solution + Participate in UATs and perform quality reviews of test results + Assist with change management and communications associated with system implementations + Contribute to business case development + Participate in project estimates **Qualifications** **Minimum:** + BA/BS in Business, Engineering, Computer Science/Information Systems, etc. or equivalent work experience. + 7 years of job-related experience in Business, IT or Engineering fields + Participation in projects of high complexity at an expert level or in a leadership role **Desired:** + Project Management Certification (PMI) + Expert knowledge of Process Improvement (eg. Lean Six Sigma principles) including the business requirements activities + Expert knowledge in Quality Management including but not limited to risk management and control development/implementation such as policies/standards, training, quality control and assurance + Extensive participation in projects of high complexity or simultaneous participation in multiple projects of medium to high complexity in a leading role + 8+ years of job-related experience in Business Analysis, which may include or be in addition to 6+ years of experience in Engineering or Information Technology + Industrial or Systems Engineer + Expert-level knowledge and working experience with multiple corresponding Line of Business-related functional areas + Extensive experience in GIS (Geographic Information System) + Detail oriented, analytical, excellent oral and written communication skills + Strong understanding of the utility business + Ability to work with different teams across disciplines and levels and promote good working environment + Demonstrates advanced understanding of the impact(s) of technical changes to the collective business processes across functional units + Good mentoring skills + Broad understanding of all relevant business processes of department(s) supported I'm Interested (https://careers.pge.com/job/Oakland-Business-System-Specialist%2C-Expert-Oakland-CA-94612/1169850500/?feedId=306700)

Description:• Receives product quality complaints (typically via phone or fax or email), from healthcare professionals and patients• Documents all incoming complaints in to complaint management system timely and notifies other QA specialists for start of investigations• Provides acknowledgement letters to the complainant upon receipt of complaint• Notifies appropriate organizations for any product replacement requests from the complainants• Conducts follow up calls to the reporters as required• Communicates any Safety events to Drug safety• Provides general support to the quality systems group including but not limited to database maintenance and report outputs• Shipment of prepaid Fedex labels to the complainant for sample return• Performs returned sample receipt, storage and assessment.• May participate in cross functional complaint related teams• May perform investigation of minor complaints• May perform basic data analysis in support of complaint investigations, trend reports and APQRs• Perform reconciliation of Drug Safety events and with Medical information• Ensure compliance with applicable regulatory requirements with current Good Manufacturing Practices (cGMPs)• Normally receives general instruction on routine work, detailed instructions on new assignments• Performs decommissioning of serialized productsAdditional Skills & Qualifications? Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or GoodLaboratory Practices (GLPs).? Demonstrates basic knowledge of pharmaceutical call center activities.? Demonstrates good verbal, written, and interpersonal communication skills.? Demonstrates working knowledge in Microsoft Office applications.? 2+ years of relevant experience in a GMP environment related field and a BS.? Prior experience in pharmaceutical industry is beneficial.? Desirable:? Able to pay attention to details, thorough documentation and multitask? Able to work well as a member of a team or group (team player)Experience Level:Entry LevelAbout ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.