Job Title: Quality Laboratory Supervisor Employee Status: Exempt
Department: Quality Laboratory Location: On-Site
Reporting To: Quality Management Work Available: Full-Time
Summary
The Quality Laboratory Supervisor is a pivotal role dedicated to ensuring the quality, purity, and regulatory compliance of pharmaceutical products spanning Small Molecules (Solid Dose) to Advanced Therapies. Operating within a rigorous cGMP environment, this role is responsible for executing complex analytical testing on raw materials, in-process samples, finished products, and stability timepoints. The ideal candidate will possess deep expertise in instrumental analysis—specifically HPLC/UHPLC, GC, and Dissolution—and will act as a Subject Matter Expert (SME) in troubleshooting, method transfer, and data integrity compliance during FDA and PIC/S regulatory inspections.
Key Responsibilities
- Routine & Advanced Analytical Testing:
- Execute analytical testing on raw materials, in-process blends, finished dosage forms (solid dose, aqueous solutions), and stability samples in compliance with compendial methods (USP/EP/JP) and in-house specifications.
- Operate, calibrate, and maintain core analytical instrumentation, including:
- High-Performance/Ultra-High-Performance Liquid Chromatography (HPLC/UHPLC) with UV, RI, and ELSD detectors.
- Gas Chromatography (GC) for residual solvent analysis.
- Automated Dissolution Testers (Apparatus 1 & 2).
- Spectroscopic equipment (FT-IR, UV-Vis).
- Wet chemistry techniques (Karl Fischer titration, potentiometric titrations, pH).
- Prepare complex mobile phases, standards, and sample solutions requiring precise quantitative techniques.
- Data Review & Regulatory Compliance:
- Ensure absolute adherence to ALCOA+ data integrity principles; document all work contemporaneously in Electronic Lab Notebooks (ELNs) and Laboratory Information Management Systems (LIMS).
- Perform peer review and second-person verification of analytical data, instrument printouts, and Empower/Chromatography Data System (CDS) audit trails to ensure 21 CFR Part 11 compliance.
- Lead Phase I Laboratory Investigations for Out-of-Specification (OOS), Out-of-Trend (OOT), and aberrant results, utilizing root cause analysis (RCA) tools to identify systemic issues.
- Draft, revise, and approve Standard Operating Procedures (SOPs), test methods, and technical reports.
- Equipment Qualification & Method Lifecycle:
- Support the Commissioning, Qualification, and Validation (IQ/OQ/PQ) of new laboratory instrumentation and software systems.
- Execute analytical method transfer and co-validation protocols (e.g., Linearity, Accuracy, Precision, Robustness) in accordance with ICH Q2(R2) guidelines.
- Diagnose and troubleshoot instrument performance issues; coordinate with vendors for preventative maintenance (PM) and out-of-tolerance (OOT) calibrations.
- Laboratory Operations & Mentorship:
- Manage the qualification, bridging, and inventory of critical Tier 1 and Tier 2 consumable reagents, HPLC columns, and USP reference standards.
- Ensure safe handling and segregation of chemical waste (flammable solvents, acids/bases, HPAPIs) in compliance with Environmental Health & Safety (EHS) guidelines.
Qualifications & Requirements
- Education & Experience:
- Bachelor’s degree (B.S. or B.A.) in Chemistry, Analytical Chemistry, Biochemistry, or a closely related scientific discipline.
- Minimum of 8+ years of hands-on analytical laboratory experience within a cGMP pharmaceutical, biotech, or contract testing organization (CRO/CDMO).
- Demonstrated leadership experience managing diverse laboratory teams.
- Technical Skills & Knowledge:
- Demonstrated mastery of HPLC/UHPLC troubleshooting, method execution, and quantitative analysis.
- Extensive experience with Chromatography Data Systems (e.g., Waters Empower 3 or Thermo Chromeleon).
- Strong understanding of FDA, PIC/S, and ICH regulatory guidelines pertaining to quality control and data integrity.
- Experience performing analytical investigations (OOS/OOT).
- Familiarity with cloud-based QMS (e.g., ACE, Master Control, Veeva) and LIMS platforms are highly preferred.
Work Environment & Physical Demands
- Ability to work in a laboratory environment requiring the use of standard Personal Protective Equipment (PPE) such as lab coats, safety glasses, and gloves.
- Ability to safely handle hazardous chemicals, active pharmaceutical ingredients (APIs), and organic solvents.
- Ability to lift up to 25 lbs. and perform tasks requiring manual dexterity and prolonged periods of standing or sitting at a bench.