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Job Req: Specialist Quality Systems and Compliance IV

Newark, CA 94560

Posted: 06/14/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 618449 Is job remote?: No Country: United States

Job Description


Quality Assurance Specialist Quality Systems and Compliance IV
Department: Quality Assurance 
Job Category: Regulatory Affairs, Compliance Job Title:
Duties: 
In support of our clients Quality Systems and Compliance initiatives, Service Provider shall perform the Services identified below and deliver to the Deliverables identified below. Services: This Scope of this contract covers the role of Quality Assurance Specialist at the Newark Facility, to support compliance of all applicable computerized systems.
• Assist Quality Systems and Compliance Team in project work for assigned computer systems assessment, implementation and enhancement projects and system rollout.
• Serve as QA Lead on systems implementation projects, quality records, and steady state activities.
• Provide support to ensure system qualification/validation activities are planned, executed, and finalized in compliance with regulatory requirements and policies and SOPs.
• Support Data Integrity program by serving as QA Lead on gap assessments, risk assessments and remediation plans.
• Develop SOPs, review and approve Validation strategy, plans, protocols, procedures. • Attend project meetings and workshops.
• Assure system artifacts are in accordance with policies, standards, SOPs and meet regulatory standards.
• Serve as QA SME under the supervision of the assigned QSC Leadership.
• Perform duties as assigned by QSC Leadership.
• Assist in the maintenance of the site-based computerized systems.
• Assist in the assessment, review, and approval of change controls, deviations, and CAPA's.
 

Skills:
Comprehensive expertise and working knowledge of 21 CFR Parts 11, 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents Extensive knowledge and competence in core Quality processes, including change control, training, deviation, CAPA, risk management, and vendor management. Strong working knowledge in validation methodology (including GAMP) and software development life cycle (SDLC) principles. Experience in providing oversight in implementing and maintaining GXP computer systems in a validated state. Excellent verbal, written and interpersonal communication skills. Effective time management and interpersonal skills. Strong organizational skills, planning skills, and must work effectively within teams. Demonstrates good coping skills and analytical problem-solving skills.


Education: BA/BS or equivalent combination of related education and experience.
Skills and Experience:
Required Skills:  QUALITY ASSURANCE, QUALITY PROCESSES, GXP, SDLC, CHANGE CONTROL
Additional Skills: ICH, QA, SOPS, COPING, REMEDIATION, ORGANIZATIONAL SKILLS, STRUCTURED SOFTWARE, TIME MANAGEMENT, TRADING, MAINTENANCE, SUBJECT MATTER EXPERT, ROLLOUT, CORRECTIVE AND PREVENTIVE ACTION
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Explore exciting job opportunities in and around Newark, California! Situated in the heart of the San Francisco Bay Area, Newark offers an unbeatable blend of career advancement and quality of life. With easy access to Silicon Valley and major tech companies, as well as the cultural delights of nearby Berkeley and Oakland, this area is a magnet for innovative professionals. Enjoy the stunning views from Mission Peak Regional Preserve, indulge in diverse cuisines along the Niles Canyon Railway, catch a show at the Fremont Center for the Arts, or cheer on the San Jose Earthquakes soccer team at Avaya Stadium. Discover why Newark, CA is the perfect place to grow your career and explore new horizons!