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Specialist Quality Systems and Compliance IV

Newark, CA 94560

Posted: 06/17/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 607800 Is job remote?: No Country: United States

Job Description


Duties:    
SERVICES and DELIVERABLES:

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 company 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 company policies, standards, SOPs and meet regulatory standards.
• Serve as QA SME under the supervision of the assigned company QSC Leadership.
• Perform duties as assigned by company 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Newark, CA

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!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.