Quality Control Laboratory Analyst

Job Title:                     Laboratory Analyst

Department:                 Quality Control

Reports To:                 Quality Control Manager

Pay Classification:      Non-Exempt, Hourly

Position Summary:      Responsible for execution of analytical laboratory tests and evaluations of product performance and processes in the Quality Control Department, in accordance with approved methodologies, policies, and associated regulations.

Duties & Responsibilities include but are not limited to:

  • Complying with cGMPs, SOPs, GLPs, safety requirements, and all company policies.
  • Performing analytical laboratory tests applied by the QC Laboratory for evaluation of raw materials, components, and products at various stages of the manufacturing process.
  • Generating and maintaining laboratory data and records in accordance with company policies.
  • Conducting product stability testing and product expiry testing in accordance with defined schedules.
  • Executing requirements for the environmental monitoring and equipment monitoring programs.
  • Participating in the validation of new methods and modifications to current methods.
  • Independently performing and adequately documenting basic investigations for out-of-specification/out-of-trend results.
  • Performing line clearance activities when requested by QA in support of manufacturing processes.
  • Assisting departmental management in the execution/implementation of projects, as requested.

Qualifications Required:

  • B.S. degree in biology, microbiology, or a related discipline
  • Experience in a Quality Control work environment, preferably in the pharmaceutical or medical device industry with knowledge of GMPs or ISO regulations is desired.
  • Microbiology experience
  • Experience in Spectroscopy and Electrophoresis
  • Technical Writing Skills
  • Proficient in MS Word and Excel
  • Excellent written/oral communication and interpersonal skills
  • BCA/Bradford Assay experience is desired.

For immediate consideration, please send a resume to srivera@chembio.com
Chembio is an Equal Opportunity Employer.