Senior QA Specialist — cGMP Pharmaceutical Manufacturing

VetJobs; Brea (CA); On-site; USD 91,000 - 101,000; Full time

Job summary

VetJobs seeks a Quality Assurance Specialist to provide real-time QA oversight on the manufacturing floor, ensuring compliance with cGMP and FDA regulations. This on-site role involves batch record review, line clearance, and support for investigations within a pharmaceutical manufacturing environment.

The ideal candidate has a Bachelor’s in chemistry or biology and 8+ years in a cGMP/FDA regulated setting, with strong document editing and SOP-writing capabilities.

Qualifications

• Must have BSc in chemistry or biology or equivalent
• 8+ years in a cGMP/FDA regulated environment such as manufacturing, QC or QA
• Broad knowledge of scientific theories, instrumentation, and analytical techniques
• Thorough knowledge of GMPs and pharmaceutical products
• Experience writing, editing, or reviewing SOPs, work instructions, batch records and guidelines
• Must read English documents such as SOPs and operating manuals

Responsibilities

• Provide QA oversight during manufacturing and warehouse operations.
• Perform aseptic processing audits and quality oversight of facilities, processes and personnel.
• Perform line clearance activities before manufacturing and packaging operations.
• Review and release of raw materials, components, and GMP materials per approved procedures.
• Conduct routine GMP observations of facilities, processes and personnel.
• Monitor production schedules to ensure adequate QA coverage.
• Manage reserve sample inventory, storage, reconciliation and retention.
• Review/approve technical documents including protocols and reports.

Skills

QA oversight

cGMP knowledge

FDA-regulated environment

Documentation/editing

Education

Bachelor’s degree in chemistry or biology

High School/GED

Job description

VetJobs seeks a Quality Assurance Specialist to provide real-time QA oversight on the manufacturing floor, ensuring compliance with cGMP and FDA regulations. This on-site role involves batch record review, line clearance, and support for investigations within a pharmaceutical manufacturing environment.

The ideal candidate has a Bachelor’s in chemistry or biology and 8+ years in a cGMP/FDA regulated setting, with strong document editing and SOP-writing capabilities.