Plant QA Partner

Overview

Plant QA Partner – Berkeley, CA

Bayer is seeking a QA professional to maintain the integrity and quality of products manufactured on the production floor. This role ensures compliance with established quality standards and regulatory requirements, safeguarding the company’s reputation and customer satisfaction. The position is mixed between Swing and Grave Shifts, Monday - Friday, 2pm - 10:30pm.

• Conduct Regular Inspections:
  Perform scheduled inspections of production processes to ensure adherence to quality standards, identifying potential quality issues before they escalate through systematic monitoring and documentation.
• Review Documentation:
  Evaluate and approve batch records and standard operating procedures (SOPs) for accuracy and compliance, ensuring all documentation meets regulatory requirements and supports operational efficiency.
• Manage Non-Conformance Issues:
  Support and approve the investigation of non-conformance issues and collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs), improving compliance and process reliability.
• Provide Training and Support:
  Deliver training and ongoing support to production staff on quality standards and best practices, fostering a quality-focused environment that enhances product quality.
• Analyze Quality Data:
  Collect and analyze quality data to identify trends and areas for improvement, enabling informed decision-making and continuous enhancement of production processes.
• Collaborate with Cross-Functional Teams:
  Work with teams across production, engineering, and supply chain to address quality issues and implement improvements through corrective actions and the PDCA cycle.
• Ensure Regulatory Compliance:
  Monitor activities to ensure compliance with regulatory requirements (e.g., GMP, ICH) and internal quality standards, minimizing risks associated with non-compliance.
• Participate in Continuous Improvement Initiatives:
  Engage in quality projects and continuous improvement initiatives aimed at enhancing product quality and operational efficiency.

Bayer seeks an incumbent who possesses the following:

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality Assurance) or equivalent experience
• Multiple years of experience in quality assurance or relevant fields
• Strong understanding of quality management systems, regulatory requirements, and industry standards (e.g., GMP, ISO)
• Excellent attention to detail and analytical skills
• Strong communication and interpersonal abilities
• Ability to work collaboratively in a team-oriented environment
• Proficiency in quality management software and tools (e.g., Trackwise, VEEVA, SAP)

• 8 or more years of experience in quality assurance or relevant fields
• Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor) is a plus
• Experience with data analysis tools and techniques

Employees can expect to be paid a salary between $ to $. Additional compensation may include a bonus or incentive compensation (if relevant). Benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

This salary range is an estimate and may vary based on location, market data, experience, degrees and certifications, and other relevant factors.

This posting will be available for application until at least 9-15-25.

Bayer is an Equal Opportunity Employer/Disabled/Veterans. Bayer is an E-Verify Employer. Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants to request needed accommodations using the contact information provided.

Location:

United States, California, Berkeley

Division:
Pharmaceuticals

Reference Code: 853032

Email: