Hands-On QA Manager, cGMP Peptide Manufacturing

CSBio Co.; Milpitas (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401k match

PTO 10 days

Paid holidays

Commuter reimbursement

Employee rewards program

Team building events

Job summary

CSBio Co. in Milpitas, CA seeks a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing and cGMP compliance. You will manage QA staff and review deviations, CAPAs, change controls, training, batch records, audits, and inspections.

The role partners with Manufacturing, QC, Materials, Facilities, Regulatory, and management to resolve quality issues and maintain readiness for regulatory inspections.

Qualifications

• Bachelor's degree in life sciences, chemistry, engineering, pharmacy, or related field.
• 5+ years of Quality Assurance or closely related cGMP experience.
• 2+ years of supervisory, lead, or functional-management experience.
• Hands-on experience with deviations, CAPAs, change controls, document control, training, batch-record review, audits, and inspection readiness.
• Working knowledge of FDA and ICH expectations and risk-based validation practices.

Responsibilities

• Supervise daily QA work and guide cGMP documentation and quality-system requirements.
• Review batch records, laboratory records, equipment and cleaning records for compliance.
• Manage deviations, CAPAs, change controls, nonconformances, investigations, and timely actions.
• Coordinate document control, SOP issuance, periodic review, archival, and controlled-copy practices.
• Support employee training assignments, qualification records, and GMP readiness.
• Prepare QA records for customer audits and regulatory inspections; track responses and commitments.
• Monitor QA metrics such as overdue investigations, CAPAs, change controls, and document reviews.

Skills

cGMP knowledge

Document review

Team leadership

Audit readiness

Regulatory knowledge

Education

Bachelor's degree in life sciences or related field

Job description

CSBio Co. in Milpitas, CA seeks a hands-on Quality Assurance Manager to supervise daily QA activities supporting peptide manufacturing and cGMP compliance. You will manage QA staff and review deviations, CAPAs, change controls, training, batch records, audits, and inspections.

The role partners with Manufacturing, QC, Materials, Facilities, Regulatory, and management to resolve quality issues and maintain readiness for regulatory inspections.