Senior QA Discrepancy & CAPA Lead — Berkeley

Bayer; Berkeley (CA); On-site; USD 115,000 - 173,000; Full time

Benefits offered by this job

Health care

Retirement plan

PTO

Job summary

Bayer in Berkeley, CA is hiring a Sr. Specialist in QA Discrepancy Management. You will evaluate incident reports and CAPAs using rigorous GMP standards to ensure timely, compliant investigations and continuous improvement across QA, QC, and operations.

The role requires collaboration across departments, leadership in training, strong written and oral communication, and the ability to manage multiple priorities while maintaining product supply and regulatory compliance.

Qualifications

• Bachelor's degree in a scientific/technical field.
• Significant experience in biopharmaceuticals, biologics, medical devices or related industry with GMP knowledge.
• Direct experience in Manufacturing and/or Quality in a GMP-regulated industry.
• Ability to review and approve incident reports (discrepancies) and CAPAs.
• Proven ability to lead cross-functional teams and communicate effectively.

Responsibilities

• Represent QA in interactions with QA, QC, Technical Operations, Supply Chain, Bayer partners, auditors and inspectors.
• Review and approve incident reports and CAPAs; enter, review, query and trend data in TrackWise.
• Lead teams to provide scientific evaluation of issues to mitigate risk and maintain product supply.
• Provide leadership in training internal customers and stakeholders.
• Write and revise SOPs; supervise and mentor Technical Reviewers.
• Monitor processes to identify opportunities for continuous improvement.

Skills

GMP knowledge

Leadership

Cross-functional collaboration

Regulatory understanding

Communication skills

Education

Bachelor's degree in a scientific/technical field

Tools

TrackWise

Job description

Bayer in Berkeley, CA is hiring a Sr. Specialist in QA Discrepancy Management. You will evaluate incident reports and CAPAs using rigorous GMP standards to ensure timely, compliant investigations and continuous improvement across QA, QC, and operations.

The role requires collaboration across departments, leadership in training, strong written and oral communication, and the ability to manage multiple priorities while maintaining product supply and regulatory compliance.