Senior Analytical QA Specialist — cGMP QC Liaison

Bachem Holding AG; California; On-site; USD 103,000 - 135,000; Full time

Benefits offered by this job

Annual bonus

Medical coverage

Dental coverage

Vision coverage

401(k) plan

Paid time off

Job summary

Bachem Americas is seeking a Sr. Analytical Quality Assurance Specialist to act as a technical liaison between Quality Control and Quality Assurance. The role provides cGMP oversight for all QC functions and documents to ensure accuracy and data integrity.

You will collaborate with QC microbiology for environmental monitoring, growth promotion, bioburden, endotoxin, water testing, and microbial ID testing. You will lead investigations and drive CAPA with a data-driven mindset.

Qualifications

• Bachelor's degree in life sciences or related field.
• Experience in a cGMP environment is required.
• Experience in Quality Assurance or Quality Control preferred.
• Strong knowledge of QC analytical methodologies and documentation.
• Proactive, self-starter with collaboration and problem-solving skills.

Responsibilities

• Support QC investigations (OOS/OOT/OOE); drive root-cause and corrective actions.
• Author/revise SOPs, work instructions, and test methods with QC.
• Review method development/validation documents and data.
• Oversee environmental monitoring, bioburden, endotoxin, water testing.
• Review stability protocols/reports and ensure data integrity.
• Lead laboratory space walkthroughs for audit readiness and safety.
• Oversee the Invalid Assay program and environmental trend reports.
• Drive risk-based investigation management and KPIs with QC.
• Support client/health authority visits, audits, and inspections.

Skills

cGMP investigations

Root cause analysis

HPLC/UHPLC

Bioburden testing

Endotoxin testing

Environmental monitoring

CAPA

Data integrity

Team collaboration

Education

Bachelor's in life sciences

Tools

MasterControl

TrackWise

Veeva

Job description

Bachem Americas is seeking a Sr. Analytical Quality Assurance Specialist to act as a technical liaison between Quality Control and Quality Assurance. The role provides cGMP oversight for all QC functions and documents to ensure accuracy and data integrity.

You will collaborate with QC microbiology for environmental monitoring, growth promotion, bioburden, endotoxin, water testing, and microbial ID testing. You will lead investigations and drive CAPA with a data-driven mindset.