Nutramaxlabs Laboratories
  • Lancaster, SC, USA
  • Full Time

The Quality Control Analyst I (QCA I) 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.  
  • Train on the operation of the following instrumentation: 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/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/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 I 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 assigned duties as may be required in 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 I should have a working knowledge of the cGMP environment.  The analyst will have 0-1 year of 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.  

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 and Biology preferred.

 

Nutramaxlabs Laboratories
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