Assurance Manager Salary in San Mateo, CA

Innova Solutions is immediately hiring for an Project Manager (Laboratory Operations)Position type: Full-time; Contract Duration: 18+ Months Location: Foster City, CA Pay range: $70 - $75/hr on W2As a Project Manager (Laboratory Operations) Professional you will:Job Description: The LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects. Additional projects may also include process-improvements related to lab functions. Job Responsibilities Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements. Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements. Ensure timely procurement of purchases by obtaining and reviewing quotes, facilitating WOs and POs, and following-up on shipping & delivery status. Facilitate the demonstration of new laboratory systems as needed. Team-up with Facilities Operations in site planning and preparation for instrument installations, including site assessments and communicating engineering/utility requirements. Collaborate with validation team members during qualification activities for GMP systems. Review documents pertaining to system implementations, including installation requirements, protocols, procedures, work instructions, and guidelines. Produce critical project documentation, including timelines in Microsoft Project, project charters, WBS, Teams communications, status update e-mails, PowerPoint presentations, lessons learned, etc. Communicate project requirements, goals, and timelines effectively via weekly project and team meetings. Assist in key project decision making efforts. Present project summaries and status updates to large groups through PowerPoint and verbal communication Organize meetings with vendors and the Vendor Service Team as needed. Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts when applicable The ideal candidate will have: Experience in managing laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements. Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.Thank you! PATHAN? SAMIULLAHKHAN Lead - Recruitment (+1) 971-925-2783PAY RANGE AND BENEFITS: Pay range: $70 - $75/hr*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.Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS 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 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.

Innova Solutions is immediately hiring for a Project Manager - II Position type: Full time time Contract Duration: 18 months Location: Foster City, CA As a Project Manager - II, you will: Job Description: LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects. Additional projects may also include process-improvements related to lab functions. Job Responsibilities • Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements • Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements • Ensure timely procurement of purchases by obtaining and reviewing quotes, facilitating WOs and POs, and following-up on shipping & delivery status • Facilitate the demonstration of new laboratory systems as needed • Team-up with Facilities Operations in site planning and preparation for instrument installations, including site assessments and communicating engineering/utility requirements • Collaborate with validation team members during qualification activities for GMP systems • Review documents pertaining to system implementations, including installation requirements, protocols, procedures, work instructions, and guidelines • Produce critical project documentation, including timelines in Microsoft Project, project charters, WBS, Teams communications, status update e-mails, PowerPoint presentations, lessons learned, etc. • Communicate project requirements, goals, and timelines effectively via weekly project and team meetings • Assist in key project decision making efforts • Present project summaries and status updates to large groups through PowerPoint and verbal communication • Organize meetings with vendors and the Vendor Service Team as needed • Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts when applicable Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible. We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW. Thank you! Namrata Gautam Senior Associate Recruitment PHONE: (+1) 314-523-1818 EMAIL: [email protected] PAY RANGE AND BENEFITS: Pay Range*: $70- $75 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 centres 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. Recent Recognitions: One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022) ClearlyRated® Client Diamond Award Winner (2020) One of the Largest Certified MBE Companies in the NMSDC Network (2022) Advanced Tier Services partner with AWS and Gold with MS 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:Main responsibility is review and release of executed batch records coming out of contract mfg / packaging vendors. Primarily packaging. These >100pages BRR.?Perform review/release of executed batch records.?Perform review/approval of various packaging documents as it applies to CXO (Contract Manufacturing /Packaging Organization.?Interface with CXO in support of routine manufacturing/packaging activities.?Performs a variety of activities to ensure compliance with applicable regulatory requirements.?Adhere to programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). ?Reviews manufacturing/packaging control data for in process and finished products. ?Review and provide information relevant to manufacturing/packaging of product at the CXO for the writing of the annual product reviews.?May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured/packaged products. ?Works with cross-functional teams during new product start-ups and product launches and identifies checkpoints for new products and processes.?Normally receives very little instruction on routine work, general instructions on new assignments.Skills:Quality assurance, Gmp, Batch record, Capa, Batch record reviewQualifications:Specific product knowledge: Pharma products in general, finished goods - not API. This is a packaging review - a lot of common sense or dealing with complex biologics. Reviewing labeling.?Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).?Demonstrates working knowledge of quality assurance systems, methods and procedures.?Demonstrates knowledge of FDA / EMEA standards and quality systems.?Demonstrates basic knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations.?Demonstrates audit and investigation skills, and report writing skills.?Demonstrates good verbal, written, and interpersonal communication skills. ?Demonstrates working proficiency in Microsoft Office applications.Education and Experience?4+ years of relevant experience in a GMP environment related field and a BS.?2+ years of relevant experience and a MS.?Prior experience in pharmaceutical industry is preferred.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.

Validation Engineer, Labware LIMSFoster City, VALength: year to start, likely extensionsResponsibilitiesValidation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)Validation testing strategy in accordance with Gilead's policy and proceduresclosely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projectswith understanding the business requirements, analyze and help translate into functional requirements for assigned LIMS projectsclosely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS applicationreview & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projectsfor Qualification protocols execution and final report view and approval for LIMS projects"Data Integrity" related- risk assessments,investigations suggest implementing remediations in CGMP operations.Data Integrity compliance/impact assessments, risk assessments, and create short executive summary reports.with the external partner or internal site to assess their DI maturity state and document the results of the assessment.Required Experience / Skills:of 6-10+ years of experience (Hiring for multiple roles Junior, Mid and Senior levels) working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.knowledge and expertise Computer System Validation, FDA& international requirements and Part 11requirements.to master technical content through interaction with subject matter experts.communication and interpersonal skills.Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.of programming and relational database concepts is required.Required Education:BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.

Job Title - Project Manager - II Contract roleLocation - Foster City, CADescription:Laboratory Operations (LabOps) Project ManagerThe LabOps Project Manager will oversee projects pertaining to the purchase, installation, and qualification of new analytical instrumentation, equipment, and software. This individual will work with project teams consisting of cross-functional team members from metrology, validation, quality control, analytical, quality assurance, and facilities operations to ensure efficient completion of these laboratory-based projects. Additional projects may also include process-improvements related to lab functions.Job Responsibilities• Manage laboratory operations projects: including the installation of new analytical instruments and equipment, new software, relocations, and process improvements• Work closely with Quality Control (QC) and Analytical Development and Operations (ADO) personnel to determine laboratory needs and user requirements• Ensure timely procurement of purchases by obtaining and reviewing quotes, facilitating WOs and POs, and following-up on shipping & delivery status• Facilitate the demonstration of new laboratory systems as needed• Team-up with Facilities Operations in site planning and preparation for instrument installations, including site assessments and communicating engineering/utility requirements• Collaborate with validation team members during qualification activities for GMP systems• Review documents pertaining to system implementations, including installation requirements, protocols, procedures, work instructions, and guidelines• Produce critical project documentation, including timelines in Microsoft Project, project charters, WBS, Teams communications, status update e-mails, PowerPoint presentations, lessons learned, etc.• Communicate project requirements, goals, and timelines effectively via weekly project and team meetings• Assist in key project decision making efforts• Present project summaries and status updates to large groups through PowerPoint and verbal communication• Organize meetings with vendors and the Vendor Service Team as needed• Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts when applicable

Your work days are brighter here.At Workday, it all began with a conversation over breakfast. When our founders met at a sunny California diner, they came up with an idea to revolutionize the enterprise software market. And when we began to rise, one thing that really set us apart was our culture. A culture which was driven by our value of putting our people first. And ever since, the happiness, development, and contribution of every Workmate is central to who we are. Our Workmates believe a healthy employee-centric, collaborative culture is the essential mix of ingredients for success in business. That's why we look after our people, communities and the planet while still being profitable. Feel encouraged to shine, however that manifests: you don't need to hide who you are. You can feel the energy and the passion, it's what makes us unique. Inspired to make a brighter work day for all and transform with us to the next stage of our growth journey? Bring your brightest version of you and have a brighter work day here.About the TeamWorkday is the leader in enterprise-class, software-as-a-service (SaaS) solutions for managing global businesses. Our solutions combine the lower cost of ownership of SaaS with a modern approach to applications. Founded by PeopleSoft veterans Dave Duffield and Aneel Bhusri, Workday delivers Human Capital Management, Payroll, Financial Management and Student solutions for midsize and large organizations.About the RoleAs an Engagement Manager in our Government practice, you will be the key player on a team that guides customers through the deployment lifecycle, solution delivery, and issue management by partnering with Workday Delivery leadership, consultants, and resource management. You will be the Workday leader responsible for managing the Customer experience through deployments. You will be tasked with managing a portfolio of project engagements, including external customer facing engagements (initial and subsequent add-on deployments) as well as internal Workday engagements.You will be responsible for ensuring the successful implementation of the Workday product on some of our largest projects for our Government customer base. The Engagement Manager will drive the client implementation and will be involved in the development of several key project deliverables (e.g., charter, project/staffing plan, issue logs, etc.) and work with the Client project manager to resolve issues that stand in the way of project success. The Engagement Manager will also be responsible for managing to the agreed upon budget and delivering the project profitably.What you'll be doing:Project manage one or more Workday product implementations concurrentlyEnsure the project is successfully delivered within the budget and time outlined in the SOWParticipate in the sales cycle when requested to gather requirements, formulate delivery approach and develop a proposal/SOWProvide guidance and mentoring to Professional Services resources working on your implementationsEnsure projects are properly planned and staffedWork with the client project manager to identify/resolve all issues that could impact project scope and/or timeframesWork with Delivery Assurance to ensure compliance with agreed to checkpointsPresent at Executive Steering Committee meetingsEnsure the client takes advantage of Workday best practicesBe a liaison for Professional Services when interacting with sales and/or developmentIdentify opportunities to position other service offeringsEnsure the client can serve as a reference upon completing their implementationAssist in the transition of the customer from Professional Services to Product SupportPresent client with change orders in the event they're asking Workday to perform tasks that are outside the scope of the SOWExpected results within 12 months:Become an expert in Workday's Implementation Methodology and use it on all engagementsDemonstrate competency in the Workday HCM, Financials, and/or Payroll product suiteFull project P+L ownershipWorkday State and Local Government Products Overview: https://www.workday.com/en-us/industries/government.htmlAbout YouBasic Qualifications:Demonstrable experience (6+ years) of project managing Medium and/or Large Enterprise ERP implementations preferably within the Federal and/or State & Local Government customer base.Prior consulting experience either as an internal consultant or with a consulting/software company.Experience implementing Workday, Oracle, PeopleSoft, SAP, Ultimate, Lawson or a similar application.Working knowledge with at least one of the following ERP business areas: Financials, HCM, Payroll, Services Procurement or similar business experience.Experience in project managing financial implementations or knowledge of financial business processes and financial reporting is desirable.Other Qualifications:Experience managing 3rd parties on a projectExperience within the Public SectorBusiness development experiencePrevious service sales experience is a plus. Successful candidates have a balance of functional (business) and technical experienceAbility to travel 50 percent or more of the timeOur Approach to Flexible Work With Flex Work, we're combining the best of both worlds: in-person time and remote. Our approach enables our teams to deepen connections, maintain a strong community, and do their best work. We know that flexibility can take shape in many ways, so rather than a number of required days in-office each week, we simply spend at least half (50%) of our time each quarter in the office or in the field with our customers, prospects, and partners (depending on role). This means you'll have the freedom to create a flexible schedule that caters to your business, team, and personal needs, while being intentional to make the most of time spent together. Those in our remote "home office" roles also have the opportunity to come together in our offices for important moments that matter.Workday Pay Transparency StatementThe annualized base salary ranges for the primary location and any additional locations are listed below. Workday pay ranges vary based on work location. As a part of the total compensation package, this role may be eligible for the Workday Bonus Plan or a role-specific commission/bonus, as well as annual refresh stock grants. Recruiters can share more detail during the hiring process. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, skills, job duties, and business need, among other things. For more information regarding Workday's comprehensive benefits, please click here.Pursuant to applicable Fair Chance law, Workday will consider for employment qualified applicants with arrest and conviction records.Workday is an Equal Opportunity Employer including individuals with disabilities and protected veterans.Are you being referred to one of our roles? If so, ask your connection at Workday about our Employee Referral process!