Quality Control Analyst
- Reputable manufacturer of specialty health products who are industry leaders in setting and adhering to high standards in manufacturing and quality control.
- Company focuses on researching and developing products to promote consumer health and is highly regarded in the industry for their advancements in the medical space.
SCOPE OF THE ROLE:
- Perform release and stability testing on raw materials and finished products following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods.
- Train in the operation of the following instrumentation: Laboratory Balances, High Performance Liquid Chromatographs (HPLCs), Gas Chromatographs (GCs), Automated Titrators, and Dissolution and Disintegration Instrumentation. The operation of additional instrumentation and/or the performance of additional test methods may also be required.
- Follow Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion.
- Report the results of analyses on raw material or finished product Certificates of Analysis (COAs).
- Generate COAs to be reviewed for release by a senior analyst.
- Review the Data Control Reports or notebook entries of other personnel, once properly trained.
- Assist with training new laboratory personnel, when applicable. All training performed under the supervision of the QCA I will be documented in accordance with established SOPs and the company training program.
- Provide input for the improvement, revision, or generation of QC Standard Operating Procedures (SOPs), Test Methods, Finished Product Specifications, and Raw Material Specifications, as appropriate.
- Maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
- 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.
· Bachelor of Sciences (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field such as Chemistry, Biochemistry, Biology.
· The QCA I should have a working knowledge of the cGMP environment.
· The analyst will preferably have laboratory experience in a cGMP facility, including experience with the proper operation of laboratory instrumentation.
· Effective interpersonal skills and the ability to interact with all levels of personnel are required.