Chemist, Quality Control
The Chemist, Quality Control role at Confidential Client involves performing chemical and physical analyses of pharmaceutical materials to ensure product quality and regulatory compliance within an FDA-regulated laboratory. Responsibilities range from routine analytical testing and documentation to complex troubleshooting, method validation, and providing technical leadership across QC levels. The position requires strong analytical skills, adherence to cGMP, and collaboration with cross-functional teams to support product release and continuous improvement.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, pharmaceutical laboratory and manufacturing (pharmaceuticals & life sciences).
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Overview
Confidential Client is hiring Chemist(s) — Quality Control (QC) at multiple levels (QC I, II, III) to join a regulated pharmaceutical laboratory near New Brunswick, NJ. This hands-on laboratory role performs routine and advanced analytical testing, supports investigations, documents results, and helps ensure product quality and cGMP compliance. Roles are non-exempt and primarily full-time.
Key Responsibilities
- Perform routine and complex chemical and physical testing of raw materials, APIs, in-process materials, finished products, and stability samples in an FDA-regulated QC laboratory.
- Operate and troubleshoot analytical instruments including HPLC/UPLC, GC, ICP-MS, FTIR/IR, UV-Vis, Auto Titrators, Dissolution Apparatus, Karl Fischer, potentiometers, and bulk density test systems.
- Prepare reagents, standards, and samples following approved procedures.
- Accurately record and document test results; follow Good Documentation Practices (GDP) and cGMP.
- Support investigations for out-of-specification (OOS) or atypical results; contribute to root-cause analysis and corrective actions.
- Maintain instrument calibration and perform routine preventive maintenance.
- Prepare and review QC documentation: test records, SOPs, protocols, and technical reports.
- Participate in customer complaint investigations, regulatory inspections, and internal audits as needed.
- Mentor and guide junior QC chemists (QC II / QC III roles provide technical leadership).
- Work extended hours or occasional weekends when required.
Responsibilities by Level
- Chemist, QC I
- Entry-level role performing routine analytical testing under supervision.
- Focus ~95% testing, ~5% documentation and record review.
- Chemist, QC II
- Independent testing, troubleshooting, data review, and limited technical leadership.
- Support investigations and revise SOPs/procedures.
- Chemist, QC III
- Senior technical resource: lead complex testing, investigations, method validation support, and mentor staff.
- Provide technical approvals and support audits/inspections.
Required Qualifications
- Bachelor's degree in Chemistry or related scientific discipline.
- QC I: 0–2 years laboratory experience (academic lab experience acceptable).
- QC II: 2–5 years QC laboratory experience; experience in regulated manufacturing (pharma, OTC, dietary supplements, or food) preferred.
- QC III: 5+ years progressive QC experience; demonstrated expertise in troubleshooting, investigations, and method validation preferred.
- Strong attention to detail, analytical thinking, and problem-solving.
- Demonstrated ability to follow procedures and maintain accurate records.
- Basic Microsoft Word and Excel skills (QC I); advanced data review and technical writing skills for higher levels.
- Familiarity with cGMP, 21 CFR Part 11 expectations, and GDP.
Preferred / Technical Experience
- Experience with chromatography and instrument software: Waters Empower, Shimadzu LabSolutions, Shimadzu LC/GC systems, Thermo ICP-MS, Nexera, GC2010.
- Prior experience in pharmaceutical or regulated QC laboratories.
- Experience with method validation/verification, compendial testing, and quality systems.
Physical Requirements & Work Environment
- Approximately 80–100% of work performed in a laboratory environment; bench-level activities standing or sitting.
- May require bending, squatting, kneeling, and lifting up to ~35 lbs occasionally.
- Use of personal protective equipment (lab coat, gloves, safety glasses/goggles, face mask, booties, respiratory protection when required).
- Exposure to chemicals, cleaning agents, odors, dust, and laboratory fumes. Follow all safety procedures and training requirements.
Compensation & Benefits
- Estimated/illustrative compensation shown on source listing: approximately $87,302/year (estimated).
- Typical benefits include medical, dental, vision, short- and long-term disability, life/AD&D insurance, matched 401(k), paid time off (vacation accrual starting up to ~10 days first year), and opportunities for overtime/shift differential where applicable.
- Specific pay and benefits will be provided by the Confidential Client during the hiring process.
Why Apply
- Hands-on, technical laboratory role with clear progression from QC I → QC II → QC III.
- Work within an FDA-regulated environment supporting product quality and regulatory compliance.
- Opportunities to develop technical expertise with modern analytical instrumentation and lead investigations or validation activities.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
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