Nutramaxlabs Laboratories
  • Lancaster, SC, USA
  • Full Time

Summary of the Position: The Quality Control Analyst II (QCA II) reports to Quality Control (QC) Management. 

Roles and Responsibilities:

  • Perform release and stability testing on raw materials and finished products following Standard Operating Procedures (SOPs), in-house test methods, and/or compendial methods.  
  • Must understand and be able to operate the following instrumentation: Laboratory Balances, High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), 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. 
  • Must be familiar with the United States Pharmacopeia (USP) and when necessary will ensure the QC Laboratory is carrying out the latest compendial methods.
  • 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/QC Chemist.
  • Review of 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 II will be documented in accordance with established SOPs and the Nutramax Laboratories 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 duties as may be required for meeting company goals and objectives.
  • Communicate effectively with other departments within the organization and function within a team environment.
  • Communicate effectively with QC management and with the QC OOS/OOT coordinator when suspect results are generated as well as with the Stability Coordinator if needed.

Minimum Requirements: The QCA II should have a working knowledge of the cGMP environment.  The analyst must have 2-3 years of laboratory experience in a cGMP facility, including experience with the proper operation of laboratory instrumentation including HPLC and GC.  Effective interpersonal skills and the ability to interact with all levels of personnel are required.  

Education and Experience: A Bachelor of Sciences (B.S.) or Bachelor of Arts (B.A.) degree in a science-related field such as Chemistry, Biochemistry or Biology is preferred.

Nutramaxlabs Laboratories
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