Senior Sterility Assurance Specialist (Contract)

Bayer AG; Berkeley (CA); On-site; USD 123,000 - 124,000; Full time

Job summary

Bayer AG in Berkeley seeks a Sterility Assurance Principal Specialist on a contract basis to support the Contamination Control and Sterility Assurance program.

This senior individual contributor role focuses on governance, metrics, risk documentation, action tracking, and inspection readiness across multiple workstreams, partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT and QRM.

Qualifications

• Minimum 8 years in pharma/biotech/sterile manufacturing environments.
• Experience supporting contamination control, sterility assurance, or GMP programs.
• Strong GMP quality systems, deviations, CAPA, change control, risk management, and documentation.
• Ability to work with cross-functional stakeholders.

Responsibilities

• Support site Sterility Assurance and Contamination Control program execution and governance.
• Maintain action trackers with owners, due dates, dependencies, risk rankings, and escalations.
• Prepare Sterility Assurance Council materials, including agendas, action logs, decisions, risk summaries, and leadership updates.
• Partner with QRM to document, prioritize, escalate risks and ensure governance alignment.
• Develop site-level sterility metrics by integrating data across QA, QC, Eng, Validation, and Ops.
• Create health summaries highlighting risk signals, overdue actions, CAPA status and contamination patterns.
• Assist with inspection-readiness activities and governance artifacts for CCS and QRM linkage.
• Coordinate deliverables across cross-functional stakeholders with clear documentation and escalation of risks.

Skills

GMP knowledge

Cross-functional coordination

Documentation

Risk management

Inspection readiness

Education

Bachelor’s degree in microbiology, biology, biotechnology, engineering, pharmaceutical sciences, or a related scientific/technical field

Job description

Bayer AG in Berkeley seeks a Sterility Assurance Principal Specialist on a contract basis to support the Contamination Control and Sterility Assurance program.

This senior individual contributor role focuses on governance, metrics, risk documentation, action tracking, and inspection readiness across multiple workstreams, partnering with Quality, QC Microbiology, Manufacturing, Engineering, Validation, Facilities, MSAT and QRM.