Chemist, Quality Control at US Pharma Lab Brunswick, NJ

Chemist, Quality Control 1

New Brunswick, NJ. 1200 Airport Road, North Brunswick, NJ

Date: 06/2020
Location: 1200 Airport Road, North Brunswick, NJ
Reports to: Manager Chemistry Laboratory
FLSA: Non-Exempt

The Chemist, QC 1 performs specific routine analysis of samples of raw materials, in process, and finished products according to established (official and/or in-house) test procedures. Testing assesses the strength, identity, purity of the test samples and/or raw materials. The Chemist prepares reagents, standards, and solutions and may monitor and verify quality in accordance with statistical process and other control procedures.

The Chemist maintains organization and compliance while working in a fast‑paced environment with changing priorities.

The Chemist, QC 2 performs similar routine analysis and additional responsibilities including troubleshooting specific batches, ensuring compliance with regulatory requirements, investigating customer complaints, and performing assigned sampling and testing in an FDA regulated lab environment.

The Chemist, QC 3 performs advanced testing, troubleshooting, and compliance duties, including root‑cause analysis, regulatory compliance, and detailed documentation in an FDA regulated lab environment.

Level 1

• Analyze organic or inorganic compounds to determine chemical or physical properties, composition, structure, relationships, or reactions.
• Conduct analysis of new samples using a wide variety of techniques, software, and scientific equipment, like HPLC, UPLC, GC & ICP-MS.
• Analyze organic or inorganic compounds to determine chemical or physical properties, composition, structure, relationships, or reactions, using chromatography, spectroscopy, or spectrophotometry techniques.
• Analyze batches of in‑coming raw materials, finished products, dietary supplements, and R&D samples to conduct routine and complex analysis of different samples to classify their physical and chemical identity.
• Conduct Method Validation, Method Verification, and Process Validation for incoming raw materials in FDA GMP‑regulated laboratory.
• Carry out routine calibration of HPLC, LC/MS (API 4000), Analytical balance and microbalance, micropipettes, pH Meter, Evaporator, and others. Maintain laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions.

Level 2

• Troubleshoot /test specific batches in order to assist in determining the root cause of off‑spec product and make recommendations for ingredient adjustments to meet required specifications.
• Ensure compliance with company and customer specifications as well as federal, state, and local regulatory requirements.
• Investigate customer complaints and provide management with test results information.
• Perform assigned sampling, physical, chemical tests and assays on raw materials, active pharmaceutical ingredients, in‑process, finished, and stability products in an FDA regulated lab environment. Use a variety of wet chemicals, physical and instrumental techniques as well as routine QC instruments (HPLC, GC, IR, Auto Titrator, Bulk Density, UV Spectrophotometer, Dissolution, Karl Fisher (KF), Potentiometer).
• Perform complicated testing with supervisory direction. Document work clearly and perform tests accurately.
• Preparation and review of QC related documents is 5% of daily activities.
• Test samples/raws as assigned and report the results. Testing activities represent 95% of daily work.
• Prepare and/or review Test Procedures, SOPs and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training.
• Comply with all regulatory/in‑house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, GLP, documentation) when performing the assigned activity.
• Must be able to work extended hours as needed and occasional weekends.
• Other duties and responsibilities as assigned.

Level 3

• Troubleshoot / test specific batches in order to assist in determining the root cause of off‑spec…