QC Chemist

We are seeking a dedicated QC Chemist to support batch release and stability programs within a cGMP pharmaceutical manufacturing environment. The role requires strong operational QC experience, particularly in solid oral dosage manufacturing such as tablets and capsules, within a fast‑paced, production‑driven setting. Job Title QC Chemist Responsibilities Conduct batch release and stability testing using chromatography (HPLC, UPLC, GC) and spectroscopy (UV‑Vis, FT‑IR). Perform assay, dissolution, impurity, and related substances testing. Operate and troubleshoot HPLC/UPLC instruments, ensuring routine calibration and maintenance. Maintain GMP documentation and ensure audit‑ready recordkeeping. Manage stability samples and trend data effectively. Collaborate daily with QA and Manufacturing to support production timelines. Conduct OOS/OOT investigations and support CAPA activities. Prepare and review validation protocols, reports, SOPs, and audit‑ready documentation. Ensure compliance with regulatory standards such as FDA, EMA, and GMP. Provide technical support and training to junior team members or other departments. Essential Skills 6–10 years of direct pharmaceutical QC laboratory experience within a cGMP manufacturing environment. Hands‑on experience with HPLC/UPLC is required. Experience using GC, UV, FTIR, dissolution equipment, and titration. Strong understanding of cGMP, FDA, ICH, ALCOA+, and data integrity requirements. Proficiency in using Empower and LIMS systems. Ability to independently process, interpret, and report analytical results. Experience with sample preparation techniques and quality control systems. Additional Skills & Qualifications Stable employment history. Strong analytical troubleshooting and data review capabilities. Excellent communication and documentation skills. Comfortable working independently and in a team‑oriented environment. Work Environment The role is based in a laboratory setting, with approximately 10 team members. The environment is focused on routine pharmaceutical QC manufacturing support, including batch release and stability testing, within a high‑throughput QC laboratory supporting daily production timelines. Job Type & Location Contract to Hire position based out of East Windsor, NJ. Pay and Benefits The pay range for this position is $36.00 – $46.00/hr. Benefits Details Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long‑term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type Fully onsite position in East Windsor, NJ. Application Deadline Position anticipated to close on Jun 5, 2026. Equal Opportunity Employment Statement The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Legal and Compliance Statements San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. #J-18808-Ljbffr