Plant Qa Partner

Description:

Bayer, a global leader in life sciences, is seeking a Plant QA Partner for its Berkeley, CA facility. This critical role ensures the integrity, safety, and quality of pharmaceutical products manufactured on the production floor. The QA Partner upholds compliance with GMP, ICH, ISO, and internal quality standards, safeguarding Bayer’s reputation while driving continuous improvement. This role is scheduled for swing and graveyard shifts (2:00 PM – 10:30 PM, Monday through Friday).

Key Responsibilities:

• Conduct Regular Inspections: Perform systematic monitoring and inspections of production processes to ensure adherence to quality standards and identify issues early.

• Review Documentation: Evaluate and approve batch records and SOPs for accuracy and compliance with regulatory requirements.

• Manage Non-Conformance: Investigate non-conformance issues, support corrective/preventive actions (CAPAs), and ensure process reliability.

• Provide Training & Support: Train and mentor production staff on quality standards and best practices, fostering a culture of quality.

• Analyze Quality Data: Collect and analyze data to identify trends, inform decisions, and drive process improvements.

• Cross-Functional Collaboration: Partner with production, engineering, and supply chain teams to resolve issues and improve processes.

• Ensure Regulatory Compliance: Maintain compliance with GMP, ICH, ISO, and Bayer’s internal QA standards.

• Continuous Improvement: Participate in quality initiatives and projects that enhance product quality and operational efficiency.

Qualifications:

• Required:

  • Bachelor’s degree in Life Sciences, Engineering, Quality Assurance, or related field (or equivalent experience).

  • Several years of professional experience in QA or related areas.

  • Strong knowledge of quality management systems and regulatory standards (GMP, ISO).

  • Proficiency with quality management tools/software (e.g., Trackwise, VEEVA, SAP).

  • Excellent analytical, communication, and interpersonal skills.

• Preferred:

  • 8+ years of QA experience.

  • ASQ Certified Quality Auditor or equivalent certification.

  • Experience using data analysis and quality improvement tools.

Compensation & Benefits:

• Salary range: $100,177 – $150,266 annually ($8,348 – $12,522 monthly).

• Additional incentive compensation/bonus eligibility.

• Full benefits package including health, dental, vision, PTO, sick leave, retirement plan, and more.

Additional Information:

• Division: Pharmaceuticals

• Reference Code: 853032

• Application deadline: Open until at least September 15, 2025.

• Bayer is an Equal Opportunity Employer and E-Verify Employer.

• Reasonable accommodations available for applicants with disabilities.