Sr. Analytical Quality Assurance Specialist

A brief overview

The Sr. Analytical Quality Assurance Specialist is a technical liaison between the Quality Control and Quality Assurance departments. This role will provide direct support and cGMP compliance oversight for all Quality Control functions and activities.

The position will be required to verify the accuracy, integrity, and compliance of analytical data, laboratory test results, and Quality Control documentation.  The role will be highly collaborative and solution-oriented, with an emphasis on partnering with Quality Control colleagues on the continuous improvement of Laboratory Systems.

What you will do Support QC-related investigations, including OOS/OOT/OOE, Deviations, and System Suitability failures.  Ensure cGMP compliance with all investigational findings and write-ups, partnering with the QC team to translate root cause into meaningful and sustainable corrective action.

Work collaboratively with the Quality Control department to author, revise, and approve standard operating procedures, work instructions, and standard test methods.

Review and approve method development and method validation documents, data, and results. Oversight will include the review and approval of associated protocols and final reports (including supporting raw data).Work closely with the QC Microbiology functions to ensure environmental monitoring, growth promotion, bioburden, endotoxin, water testing, and microbial  are performed in a timely manner, per procedure, and properly evaluated against established acceptance criteria.

Review and approve stability protocols, ensuring study design meets client and cGMP requirements.  Review and approve stability reports, including the review of reportable data packets, ensuring that the study intent has been met, acceptance criteria have been met, and that any exceptions (e.g. deviation or OOS results) are properly documented and addressed within the report.

Provide quality oversight for QC studies, including study design, acceptance criteria, execution, reporting, and approval.

Perform functional area walkthroughs of the laboratory space(s) to ensure proper housekeeping, audit readiness, safety, data integrity, sample/reagent/ reference standard integrity, and procedural compliance.  Report findings to an authorized QC representative and work with the QC team to remediate any noted deficiencies.

Ensure proper oversight of the Invalid Assay program.

Review and approve Environmental Monitoring trend reports.

Champion and drive a risk-based approach within investigation management, data analysis and oversight, document revision, and good laboratory practices.

Assist with the development of metrics and/or KPIs, translating emerging trends into partnership with QC to identify areas of improvement from a systematic perspective.

Support client and health authority requests, site visits, audits, and inspections as required.

Qualifications Bachelor’s degree in life sciences or related field8+ years in a cGMP environment5+ years working in Quality Assurance and/or Quality Control3+ years in Quality Control3+ years in the Pharmaceutical, Biopharmaceutical, or Medical Device industries

Strong applied knowledge of cGMP investigations, including deviations, out-of-specification, and environmental excursions.

Strong applied knowledge of common Root Cause Analysis tools and techniques, including the use of proper interviewing technique, 6M Methodology (Fishbone), 5 Whys, Is / Is-Not.

Strong Technical and applied knowledge of common QC analytical methodologies, with an emphasis on HPLC, UHPLC, GC, Karl Fisher, and FTIR.Strong experience authoring or reviewing various technical QC documents and records, including Method Development, Method Transfer, Method Qualification, standard…