QC Laboratory Analyst I

ALLSTAFF

QC Laboratory Analyst I

 

Purpose and Scope:

The Quality Control Laboratory Analyst I is primarily responsible for daily performance of the testing of all raw materials, batches, and finished goods.

 

Essential Job Functions:

  • Test and release applicable raw materials.
  • Test and release bulk batches.
  • Complete finished goods testing.
  • Complete stability testing.
  • Ability to preform analytical and microbial testing.
  • Preparing as needed and shipping samples for outside microbiological and analytical testing.
  • Prepare and execute in-house microbiological testing for environmental and production samples.
  • Prepare and execute analytical methods based on Approved Laboratory Methods.
  • Assist in ordering and maintaining stock of all laboratory equipment and chemical standards.
  • Assist QC Manger and QA/RA Manager in developing and maintaining laboratory GLP’s.
  • Monitor work activities to ensure adherence to Standard Operating Procedures, QA Manuals and programs.
  • Assist with developing new testing validations and methods on Analytical Equipment
  • Provide QC assistance and support to managers, supervisors, and manufacturing personnel.
  • Undergo training on SOP’s as listed on the accompanying Training Matrix.
  • Participate and interact in internal and external training programs.
  • Other duties as assigned

 

Requirements:

  • 0–3 years laboratory experience or the equivalent combination of education (associate degree, or relevant life science courses and experience).
  • Understanding or Previous experience in a GMP and GLP environment.
  • Proficiency with Microsoft Office (Excel and Word)
  • Understanding and knowledge of pharmaceutical cGMP, FDA guidelines and industry standards.
  • Must be well organized.
  • Ability to work effectively in a team.
  • Technical writing skills.
  • Multitasking and attention to detail.
  • Must be able to work independently.
  • Ability to handle confidential company data, projects, information, etc.