Quality Control (QC) Chemist

Quagen Pharmaceuticals; West Caldwell (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Quagen Pharmaceuticals is seeking a detail-oriented QC Chemist to perform critical testing on raw materials, APIs, in-process samples and finished products in a cGMP environment. You will document results with high accuracy, maintain logs and participate in investigations of deviations and OOS results.

The role requires a Bachelor’s degree in chemistry or related field and at least 2 years of pharmaceutical QC experience, with Empower-3 experience a plus.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy or related field.
• Minimum 2 years of experience in a pharmaceutical QC laboratory or regulated cGMP environment preferred.
• Hands-on experience with Empower-3 is a plus.

Responsibilities

• Perform sampling, physical and chemical tests on raw materials, APIs, in-process samples, finished goods and stability products.
• Utilize wet chemistry, physical methods and major instruments (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, etc.) following USP, in-house or compendial monographs.
• Document results clearly and record data and transcribe information onto report sheets and lab notebooks per SOPs.
• Comply with safety protocols, manage chemical waste, maintain laboratory housekeeping and adhere to cGMP/cGLP guidelines.
• Maintain proper laboratory logbooks and actively participate in investigations regarding deviations and OOS results.
• Perform other routine laboratory duties as assigned by management.

Skills

Documentation

Organizational skills

Communication skills

Detail-oriented

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Pharmacy or related field

Tools

Empower-3

Job description

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.

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.