Senior Quality Laboratory Analyst

Job Description

Job Description

JOB SUMMARY

The Senior Quality Laboratory Analyst (Analytical Chemist) 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

1. 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.

2. 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.

3. 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.

4. 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 / TRAINING

• 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).

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, MasterControl, Veeva) and LIMS platforms is highly preferred.

• 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.

CORE COMPETENCIES

• Strong leadership, coaching, and communication skills. 
• High decision‑making aptitude and risk‑based thinking. 
• Proficient in data trending, problem‑solving, and scientific writing. 
• Exceptional organization, prioritization, and follow‑through. 
• Ability to operate independently with minimal supervision. 
• Strong competency with Microsoft Office and electronic quality systems.