Biotechnology / Pharmaceuticals 12+ Months Contract Position Summary We are seeking an experienced QA Specialist (C&Q / Validation) to oversee and support commissioning, qualification, and validation activities at a biopharmaceutical manufacturing facility. This role serves as the Quality authority ensuring all facility equipment, clean utilities, and bioprocess systems strictly comply with cGMP standards, FDA/EMA regulations, and risk-based validation frameworks (ASTM
Review and approve User Requirements Specifications (URS), Commissioning protocols, and
IQ/OQ/PQ
protocols and summary reports for clean utilities, process systems, and computerized systems.
Validation Lifecycle Execution:
Provide quality oversight on validation protocols and final reports, covering cleaning validation, process validation, and technology transfer documentation.
Design & Risk Review:
Review system impact assessments, equipment criticality categorizations, and design documentation alongside engineering and qualification teams.
Quality Systems Support:
Act as the QA point of contact for non-conformances, deviations, CAPAs, and change controls associated with C&Q and validation execution.
Vendor & Lifecycle Support:
Review vendor-leveraged documentation (FAT/SAT), commissioning test results, and technology transfer packages to ensure regulatory audit readiness.
Continuous Improvement:
Develop, revise, and approve Standard Operating Procedures (SOPs), work instructions, and documentation tools to streamline site compliance systems.
Cross-Functional Partnership:
Collaborate with Engineering, Maintenance, Manufacturing Operations, MSAT, and QC to mitigate compliance risks during facility startup, expansion, or ongoing operations.
Minimum Qualifications Education:
Bachelor's degree in a scientific, biomanufacturing, or engineering discipline (e.g., Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biochemistry).
Experience:
2-4 years of direct quality assurance or validation experience within the biopharmaceutical or biotechnology manufacturing industry.
Technical Domain Knowledge:
Direct experience with clean utilities (Water for Injection [WFI], clean steam, process gases, HVAC, CIP/SIP). Direct experience with bioprocess equipment (bioreactors, centrifuges, ultrafiltration/diafiltration [UF/DF], chromatography skids, autoclaves, BSCs, and isolators).
Regulatory & Framework Proficiency:
Working knowledge of c
GMP, FDA 21 CFR
Part 11/210/211, EMA guidelines, and ISPE Baseline Guides (including ASTM E2500 and GAMP 5 principles).
Quality Systems:
Direct hands-on background managing deviation investigations, CAPAs, and Change Controls within electronic tracking systems (e.g., TrackWise, Veeva).
Communication:
Proven technical writing capability and cross-functional interpersonal skills
Pay:
$32.08 - $38.64 per hour Expected hours: 40.0 per week
