Quality Laboratory Supervisor

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Professional Dallas, TX, US

Salary Range: $75,000.00 To $95,000.00 Annually

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 time points. 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.

• 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.

• 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).
• Dem…