Quality Control (QC) Chemist
Quagen Pharmaceuticals
Summary
We are seeking a detail-oriented and Quality Control (QC) Chemist to join our pharmaceutical manufacturing team. In this role, you will perform critical physical and chemical testing on raw materials, in-process samples, and finished products to ensure compliance with cGMP, cGLP, and regulatory standards.
Job description
Key Responsibilities
- Perform assigned sampling, physical, chemical tests, and assays on raw materials, active pharmaceutical ingredients (APIs), in-process samples, finished goods, and stability products.
- Utilize wet chemistry, physical methods, and major instruments including HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto Titrator, and Bulk Density apparatus according to USP, in-house, or compendial monographs.
- Document all work clearly and perform tests with high accuracy. Record data, results, and transcribe information onto report sheets and laboratory notebooks exactly as specified by Standard Operating Procedures (SOPs).
- Comply with safety protocols, manage chemical waste, maintain laboratory housekeeping, and adhere to cGMP/cGLP guidelines at all times.
- Maintain proper laboratory logbooks and actively participate in laboratory investigations regarding deviations and Out-of-Specification (OOS) results.
- Perform other routine laboratory duties and tasks as assigned by management.
Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy or related scientific discipline.
- Minimum 2 years of experience in a pharmaceutical QC laboratory or regulated cGMP environment preferred.
- Hands on experience with Empower-3, a plus.
- Strong documentation, organizational and communication (written & verbal) skills.
Physical Demands/Environmental Conditions
- Laboratory environment.
- Able to lift about 25 pounds.
- Able to stand and or sit for longer period of time.
Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy or related scientific discipline.
- Minimum 2 years of experience in a pharmaceutical QC laboratory or regulated cGMP environment preferred.
- Hands on experience with Empower-3, a plus.
- Strong documentation, organizational and communication (written & verbal) skills.
Company overview
Quagen Pharmaceuticals is a fully integrated pharmaceutical company specializing in the development, manufacturing, and distribution of high-quality, affordable generic medicines. Founded in May 2016 and headquartered in West Caldwell, New Jersey, the company operates from three state-of-the-art FDA-approved cGMP manufacturing facilities spanning 170,000 square feet. Led by entrepreneur Ashish Shah, Quagen produces a diverse range of prescription and over-the-counter medications including solid orals, liquids, topical creams, suppositories, and transdermal patches. The company maintains strict compliance with cGMP regulations and DEA scheduling requirements for controlled substances from Schedule I to V. With approximately 78 employees and senior management boasting over 75 years of combined industry experience, Quagen leverages innovative platform technologies and proprietary know-how to deliver safe, effective pharmaceutical products trusted by healthcare professionals and patients worldwide. The company's capabilities encompass complete turnkey solutions from formulation development and analytical testing to final manufacturing and marketing.