Quality Analyst

Job ID: BH34565

Category: Quality Assurance (QA)

Position Summary:

Responsibilities and experience may include the following: Data entry of analytical data. Data trending and archiving. Revise SOP's as needed. Read, understand and follow SOP's and comply with GMP's. Complete acquaintance with and understanding of the general and detailed aspects of the job, their practical applications to problems and situations ordinarily encountered. Complete understanding of the general and detailed aspects of the job, practical applications to problems and situations ordinarily encountered.

Additional Job Functions:

  • Accurately perform testing, maintain documentation and prepare reports in association with the performing of assays.
  • Maintain supply levels for performance of assigned duties.
  • Maintain accurate and updated lab records.
  • Follow all safety regulations as indicated in the client Policies and Procedures and accepted lab practices.
  • Detail oriented

List of duties:

  • Data entry of analytical data into computer systems.
  • Sampling of WFI and purified water systems, clean steam and compressed gases.
  • Perform Environmental Monitoring and collect cleaning verification samples.
  • Testing of water and product samples including conductivity, bioburden, endotoxin, TOC, A280, water analysis, osmolality, biological indicators.
  • Maintain lab instrumentation.
  • Read, understand and follow SOP's and comply with GMP's.
  • Logbook and Data archiving.
  • Participate in QC project teams to accomplish effective results.
  • Check expiration dates for media, reagents and logbooks
  • Request new logbooks and update SOP manuals
  • General lab cleaning, login and maintaining lab supplies
  • Accurate preparation of laboratory solutions.

Typical Education: B.S. in a Scientific Field with coursework and labs in Microbiology.

Typical Experience: 0-1 years experience

Technical Knowledge: cGMP knowledge

Language Skills: Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

Mathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability: Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.

Computer Skills: Outlook, Explorer, Excel, Word