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Conformance & GMP Projects Specialist

Berkeley, CA 94710

Posted: 11/25/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 616082 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 45-53.05/hr **salary will be commensurate with experience 

POSITION SUMMARY:
Focus is internal. Leads cross-functional teams and interfaces with external groups on tasks/assignments relating to deviation and change management. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

POSITION DUTIES & RESPONSIBILITIES:
Deviation Management
• Investigate discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence.
• Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement
• Influences direction of investigations and communicates with all levels of employees
• Write concise, accurate and effective deviation reports for investigations that meet compliance expectations
Change Management
• Coordinate and manage change applications (Local and Global).
• Maintain alignment of Global Standard Operating procedures (GSOP) and Operational Instructions (GOI) to local procedures.
• Support CMS Chapter Owners and Representatives by maintaining compliance. Update and upgrade CMS Chapters.
• Support process development/improvement projects, site-wide and global projects.

REQUIREMENTS:
Education Requirement(s):
• Minimum Education B.S. degree in a Science related field, i.e. Engineering, Biology, Chemistry, etc.
• Minimum Experience BS 6+ years
• MS 0-4+ years of experience in a related field such as: Engineering, Quality, or Manufacturing in the pharmaceutical industry or an equivalent combination of education and experience
Skill & Competency Requirements: (list 3 to 5 non-negotiable items such as years of experience, industry of preference, specific knowledge items, professional certifications, skills, abilities, etc.)
MUST have experience/expertise in cell and gene therapy manufacturing
• Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation and control systems, etc.
• Experience with regulatory and cGMP requirements for pharmaceutical manufacturing
• Strong analytical skills to identify root causes and prepare balanced decisions
• Ability to plan and prioritize complex and conflicting activities; act in a speedy and pragmatic manner, adapt quickly to changing environments, without sacrificing quality and long-term goals.
• Strong written and verbal communication skills, and effective presentation skills and ability to adjust presentation style to accommodate various audiences.

Preferences: 
• SAP, ValGenesis
• Deviation Management/Quality Management Software (e.g. Trackwise, Sparta, Werum Pas-X)
• Risk Assessments
• Authoring/Reviewing Documents for Regulatory Review
• Lean Six Sigma and Continuous Improvement Methodology
• Project Management Professional (PMP)

Travel Requirements: (if applicable)
• None
 

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 is an equal opportunity employer. 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 Berkeley, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant area surrounding Berkeley, California. Known for its innovative spirit, proximity to the bustling San Francisco Bay Area, and the prestigious University of California, Berkeley, this region offers a perfect blend of career growth and quality of life. With its diverse culture, world-class dining scene, renowned art galleries like the Berkeley Art Museum and Pacific Film Archive, as well as outdoor spaces like Tilden Park and the Berkeley Marina, this area provides an enchanting backdrop for your professional journey. Join us in discovering the opportunities that await you in this dynamic and charming locale.

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.