QA Specialist Salary in California, USA

Innova Solutions is immediately hiring a Manager QA Documentation Specialist - III Position type: Full-time Contract Duration: 6 months and possibility for extension Location: REMOTE As a QA Documentation Specialist - III, you will:Ensures the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents. Maintains documentation manuals to ensure accuracy and current information. Ensures the correct and timely input of database entries, verifies own work. Supports the distribution and maintenance of GXP documentation. Scans, verifies and archives documentation as needed Recommends process improvements and proposes changes. Provides support with internal and regulatory audits/inspections as required. Provides user training for electronic systems (as applicable).Creates and maintains document templates. Assists with the periodic review process. Supports the maintenance of monthly document control metrics. Performs general word processing tasks and support. Checks format and conformance to document templates, verifies own work. Provides additional support and assistance on tasks and projects as directed by management. Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues. *APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. Thank you! Vishnu Kaushik Email: [email protected] Phone - 678-207-5230 PAY RANGE AND BENEFITS: Pay Range*: $35- $37 per hour *Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc. Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP). ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.Website: https://www.innovasolutions.com/ Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected] or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

Description:• Performs and/or assists with QA review of production records and Lab reports.• Investigates non-conformance and deviation reports.• Coordinates the stability studies including reviewing laboratory reports for accuracy and preparing statistical analyses of decay curves.• Review test results for and release raw materials.• Audits production and quality control programs, reports observed deficiencies, and contributes to establishing solutions to observations.• Issues batch records, checks yield and reconciliation calculations, and fiels records for easy retrieval.• Manages validation programs related to manufacturing equipment and processes and calibration of physical testing equipment.• Receives, logs, investigates, and reports on complaints and adverse events; coordinates responses with QA Manager.Skills:Gmp, batch record review, Document control, non conforming, fdaTop Skills Details:Gmp,batch record reviewAdditional Skills & Qualifications:bachelors degree in a life science3-5 years in quality assuranceExperience 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.

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

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.

Description:20% BRR80% Analytical focused• Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements • Serves as QA Lead for clinical and commercial projects. • Leads quality investigations/deviations/quality event escalation meetings and effectively communicates and escalates major and/or critical events to upper management in a timely manner. • Reviews and approves method validation and/or transfer documents, including protocols, reports, methods, change controls, and specifications for small molecules and/or large biologics for analytical operations and contract labs/manufacturers across the clinical and commercial supply chains. • Reviews manufacturing records, environmental monitoring, and quality control data for in-process and finished products. • Reviews method validation-related data in CMC sections of NDA / global filings. • Responsible for maintaining current knowledge of the Compliance Program and applicable company standard operating procedures for areas of responsibility. • Interfaces with operating entities and contract partners to address documentation and compliance issues and ensure successful project completion. • Review stability documents and contribute to APQR• Reviews and improves existing quality procedure workflows and identifies areas of improvement for efficiency and compliance. • Responsible for providing quality metrics, trend reviews, and risk assessments. • Participates in projects, initiatives, and process improvements. • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. • May assist with cGMP compliance audits at contract partners and may interface with regulatory agencies during inspections.Skills:analytical chemistry, method validation, HPLC, UPLC, tech transfer, quality assurance, deviationQualifications:• 10 years of experience in a GMP environment-related field (analytical laboratory experience, specifically method development or method validation) and a BS or BA. • 3+ years of relevant experience (analytical laboratory experience, specifically method development or method validation) and an MS. • Prior experience in the pharmaceutical industry is required - preferred small molecule, oral solid dose, but open to large molecule.• Possesses experience/knowledge in laboratory controls, method validation, and method transfer guidelines per FDA/EU/ICH/USP/JP guidelines. • Strong background in laboratory investigations (OOS, OOT, Atypical), deviations, and associated CAPAs. • Proficient in applying FDA OOS Guidance, MHRA OOS Guidance, and general QA principles, concepts, industry practices, and standards. • Proficient in Root Cause Analysis Tools (e.g. Fishbone Diagrams and Failure Mode Effects Analysis, 5 Whys). • Working knowledge of Risk Management Tools (e.g., root cause analysis, decision trees, risk registers). • Experience in a Pharma / Biotech GMP environment and a bachelor's degree in chemistry, biology, or related scientific fields. • Expertise in Quality Systems and cGMP standards applicable to method validation for clinical and commercial products and AO/QC laboratory operations. • Demonstrates excellent attention to detail and ability to meet high-quality standards required in QA Compliance consistently. • Ability to work independently and effectively coach peers in a high-paced environment with tight timelines while maintaining accuracy and quality. • Possesses critical thinking skills when making sound quality decisions based on risk management and available data. • Has proven analytical and conceptual skills. • Ability to effectively generate metrics and presentExperience 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: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.

Medix is currently hiring for a Quality Specialist to partner with a client through at least the end of the 2024 year! Do you have a background in QA supporting a biotech, med device or pharma manufacturing group? If so, consider applying today. Primary Responsibilities:Perform investigations per established proceduresSupport problem solving and troubleshooting as part of investigationsGenerate quality records as needed (CAPAs, CCs) to support process improvementsReview laboratory records (test packets, logbooks, etc.) and ensure they have acceptable Good Documentation Practices and are following proceduresUpdate and draft standard operating procedures and work instructionsCommunicate effectively with all team membersMinimum Qualifications:Bachelor's Degree in a scientific, engineering, or other technical discipline4 years of experience in a quality assurance setting in biotechnology, medical device or pharmaceutical setting Strong understanding of 21 CFR parts 210 and 211Direct experience in record review, investigations, and root cause analysisGood understanding and compliance with principles of Good Documentation PracticesStrong organizational and time management skillsExcellent attention to detailStrong analytical skillsSucceed when working independently and as part of a teamDemonstrated work ethic and accountabilityPreferred Qualifications:Experience working within a quality system or QMS (e.g. Veeva)Thrive in a fast paced, growing, and dynamic work environment

We are currently looking for an experienced Release Management Engineer to join our team with one of our clients. I would like to tell you a bit more about this position and learn a few things about you, as well.Job Title: Release Management EngineerLocation: San Jose CA - HybridContract to HireJob Description:As a Release Management Engineer, you will play a crucial role in maintaining and monitoring software builds while contributing to the design of the infrastructure supporting software. You'll be responsible for conducting, managing, and delivering all software releases, including planning the release of project deliverables and engineering new solutions. Collaboration is key as you work with various teams to ensure continuous integration, manage changes within the scope of a release, and mitigate risks effectively. Your expertise will also be integral in managing the software release process from concept to deliverables, ensuring compliance with quality standards and customer expectations.Responsibilities:Plan, build, test, prepare, and deploy software updatesConduct release readiness and milestone reviewsCollaborate with QA and Development Departments on crucial release plansLiaise with stakeholders to manage issues, requests, and conflictsImplement escalation and support frameworksEnsure compliance with quality standards and customer expectationsConduct weekly release reporting to the leadership team and executive managementRequired Skills:Strong understanding of QA methodologies, software development lifecycle, and release managementExperience with automation, manual testing, regression, test cases & plans, and cloud technologiesProficiency with tools such as Jira, Confluence, Jenkins, Docker, and WebDriverFamiliarity with Linux, Rest API's, AWS, Azure, or GCPKnowledge of Agile or Waterfall methodologiesExperience with Python, Java, Selenium, and full-stack technologiesUnderstanding of networking, security, packets, Wireshark, and IXIAAbility to manage change and communicate effectively with team and stakeholdersExcellent time management skills to meet deadlinesContinued studies to stay updated on technical processes, methods, and toolsQualifications:Bachelor's degree in Computer Science or equivalent experience5-6+ years of experience in release management or a related fieldExcellent communication skills - verbal, written, and technical

Lead QA Engineer- Must have knowledge of AS9100 terminology and onsite - Camarillo (near Ventura) N. Los AngelesSalary: $110,000 - $135,000 K + Stock Option+ Great Benefitsrequirements -US CITIZEN ONLYMust have exp with AS9100 documentation process - HardwareThe Lead QA Engineer is responsible for AS9100 & AS9115 compliance. He/she works with various departments to maintain, document, train and improve the QMS with the organizational freedom and unrestricted access to top management to resolve QMS issuesThis position is exempt, requires a 40-hour workweek and overtime as needeWHO IS THE PERFECT CANDIDATEBachelor's Degree (B.A./B.S.) in Engineering, Manufacturing, or related field from an accredited four (4) year university.knowledge of AS9100 terminology and requirements,Electronics QA testing (i.e VOIP) Military and Aerospace applications. nice to havestrong written and documentation skills,familiarity with electronics hardware and software engineering design process,familiarity with electronics manufacturing operations and procedures. The ideal candidate .. may have audit experience which is helpful, but not sufficient. Usually auditors determine if a company's procedures correctly implement AS9100 by reviewing their documentation records. But observing and verifying compliance (a bureaucratic skill) is a different skill set from the creative ability to design and implement customized systems and documentation that can be easily maintained.Responsibilities:Conduct Internal QMS audits to analyze QMS to the AS9100 & AS9115 standard, identifying and documenting any/all gaps in current processes that exist and correct when required. Ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.Work effectively with all departments to develop and improve QMS ensuring product reliability, consistency, and traceability.Provide quarterly quality status presentations and scorecards to management that: Use quantitative measurement and analysis to identify and reduce problems in production with analysis of product returns, scrap, labor rates, purchased parts, and trends over time. Reporting on the performance of the QMS and on opportunities for improvement particular to top management.