Sr. Analytical Quality Assurance Specialist

Bachem AG•Vista, CA

8d•$97,972 - $134,712

About The Position

The Sr. Analytical Quality Assurance Specialist is a technical liaison between Quality Control and Quality Assurance, providing direct support and cGMP compliance oversight for Quality Control functions and activities. The role verifies the accuracy, integrity, and compliance of analytical data, laboratory test results, and Quality Control documentation. It is highly collaborative and solution-oriented, partnering with QC colleagues to continuously improve Laboratory Systems. The specialist supports investigations and reviews or approves analytical, microbiological, stability, and other QC documents and studies. The role also conducts laboratory walkthroughs, oversees programs and trend reporting, advances risk-based quality practices, supports quality metrics and improvement initiatives, and responds to client and health authority requests, site visits, audits, and inspections as required.

Requirements

Bachelor’s degree in life sciences or a related field.
At least 8 years in a cGMP environment.
At least 5 years working in Quality Assurance and/or Quality Control.
At least 3 years in Quality Control.
At least 3 years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries.
Strong applied knowledge of cGMP investigations, including deviations, out-of-specification results, and environmental excursions.
Strong applied knowledge of root cause analysis tools and techniques, including proper interviewing technique, 6M Methodology (Fishbone), 5 Whys, and Is / Is-Not.
Strong technical and applied knowledge of common QC analytical methodologies, especially HPLC, UHPLC, GC, Karl Fisher, and FTIR.
Strong experience authoring or reviewing technical QC documents and records, including method development, method transfer, method qualification, standard test methods, standard operating procedures, stability protocols and reports, chromatograms (raw data packages), scientific notebooks, and logbooks.
Proficient with Corrective and Preventive Action (CAPA), including establishing and measuring effectiveness checks.
Experience reviewing and interpreting microbiological data, including bioburden, endotoxin, air viable, surface viable, microbial ID, colony morphology, B&F, and environmental monitoring risk assessment.
Proficient with change management governance, concepts, control points, and workflows.
Experience with data entry, sorting, analysis, and presentation in support of site Quality Metrics and Key Performance Indicators.
Experience with industry Quality Management Systems, such as MasterControl, Trackwise, and Veeva.
Proven problem-solving skills and experience.
Proactive and self-starting; willing to seek help or guidance when required.
Strong collaboration skills, ability to build trust and partnership with stakeholder departments, and experience using conflict resolution and teamwork to drive positive change.

Responsibilities

Support QC-related investigations, including OOS/OOT/OOE, deviations, and system suitability failures; ensure cGMP compliance in investigation findings and write-ups and partner with QC on meaningful, sustainable corrective actions.
Collaborate with Quality Control to author, revise, and approve standard operating procedures, work instructions, and standard test methods.
Review and approve method development and method validation documents, data, results, associated protocols, final reports, and supporting raw data.
Work with QC Microbiology to ensure environmental monitoring, growth promotion, bioburden, endotoxin, water testing, and microbial identification testing are timely, performed according to procedure, and evaluated against acceptance criteria.
Review and approve stability protocols and reports, including reportable data packets, to ensure study design meets client and cGMP requirements, study intent and acceptance criteria are met, and exceptions are documented and addressed.
Provide quality oversight for QC studies, including study design, acceptance criteria, execution, reporting, and approval.
Conduct functional area walkthroughs of laboratory spaces to assess housekeeping, audit readiness, safety, data integrity, sample/reagent/reference standard integrity, and procedural compliance; report findings and partner with QC to remediate deficiencies.
Ensure proper oversight of the Invalid Assay program.
Review and approve Environmental Monitoring trend reports.
Champion and drive a risk-based approach to investigation management, data analysis and oversight, document revision, and good laboratory practices.
Assist with developing metrics and KPIs and translate emerging trends into QC partnerships to identify systematic improvement areas.
Support client and health authority requests, site visits, audits, and inspections as required.