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- Perform release, stability and special request testing of finished products and raw materials following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods.
- Will assist when needed in evaluating new testing applications and instrumentation, either with developing new methods or adopting compendial methods. Will aid in transferring new methods for routine QC use. If needed, will assist to ensure methods are accurate, precise, and robust for use of testing release samples.
- Train on the operation of the following instrumentation but not limited to: Laboratory Balances, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Automated Titrators, FTIR, UV/Vis Spectrophotometer, Polarimeter, Dissolution and Disintegration Instrumentation. The operation of additional instrumentation and the need to train on new laboratory test methods when required.
- Stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control laboratory complies in the areas of analytical applications, release specifications, and documentation practices.
- Assist QC management and/or designee in resolving Out of Specification results in the QC Laboratory. Communicate effectively with QC management and with the Out-of-Specification/Trend Coordinator when suspect results are generated as well as with the Stability Coordinator when needed.
- Assist in training new laboratory personnel and document training in accordance with established laboratory SOPs and the training program.
- Follow Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion.
- Maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
- complete specific projects assigned by management and other necessary functions.
- Perform other assigned duties as may be required in meeting company objectives.
- Communicate effectively with other departments within the organization and function within a team environment.
Must have 5 – 7 years of laboratory experience working in a cGMP environment. Experience preferred with operation of laboratory instrumentation including Gas Chromatography (GC) and/or Liquid Chromatography (LC), troubleshooting, generation and revision of operating procedures and test methods.
A Bachelor of Science (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field such as Chemistry, Biochemistry or Biology preferred.