• Conduct analysis and testing of finished products and raw materials according to Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods for release, stability, and special requests.
• Learn to operate and maintain a range of laboratory instruments, including Laboratory Balances, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Automated Titrators, FTIR, UV/Vis Spectrophotometer, Polarimeter, Dissolution and Disintegration Instrumentation, and any additional instruments as required.
• Stay updated on publications from governing bodies like USP and FDA to ensure compliance with analytical applications, release specifications, and documentation practices in the Quality Control laboratory.
• Collaborate with QC management and designated personnel to resolve Out-of-Specification results. Communicate effectively with QC management, Out-of-Specification/Trend Coordinator, and Stability Coordinator when suspect results are generated.
• Assist in the training of new laboratory staff and maintain accurate training records following established SOPs and training program guidelines.
• Adhere to Current Good Manufacturing Practice (cGMP) guidelines for documentation and record all procedures in a timely manner.
• Maintain a safe working environment by ensuring calibration and proper maintenance of all testing equipment.
• Take on specific projects assigned by management and fulfill other necessary functions required to meet company objectives.
• Effectively communicate and collaborate with other departments within the organization, fostering a team-oriented environment.

Requirements:

Minimum 5 - 7 years of laboratory experience in a cGMP environment. Experience with laboratory instruments, troubleshooting, operating procedures, and test method generation and revision preferred.

Education:

Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in Chemistry, Biochemistry, or Biology, or a related field.