Overview

Apex Systems is looking for a Quality Control Analyst III to work with our client in Harmans, MD near BWI. For applicants who are interested in this opportunity, please apply directly and send a Word resume to

Position: Quality Control Analyst III

Location: Harmans, MD 21077

Duration: 6m Contract to Hire

Shift: 8-5 M-F (OT available)

Responsibilities:

  • Experience with the transfer/qualification/Validation of GMP assays such as ELISA, qPCR, RT-PCR, HPLC and Capillary Electrophoresis.
  • Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC and Capillary Electrophoresis.
  • Generate internal and external documents such as assay protocols, summary reports, and SOPs.
  • Assist with investigations related to assay performance. Work on project teams developing and improving assays.
  • Work with clients during initial and subsequent transfer of assays and analytical methods to support GMP manufacturing campaigns.
  • Provide instrumentation care, maintenance, troubleshooting, and data interpretation.
  • Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility and products manufactured.
  • Document writing (laboratory investigations, out of specifications, deviations, CAPAs), data interpretation/presentation, statistical analysis, and trending.

Requirements:

  • Bachelor in a Sciences discipline and 4-6 years of experience working in a GMP Quality Control Lab with some or all of the time working with method transfer & qualification.
  • MUST HAVE ELISA EXPERIENCE
  • Considerable knowledge/expertise relevant to QC analytical methods used for protein chemistry and molecular biology.
  • Experience within the biologic, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices.
  • Experience in writing SOPs and test methods as well as method qualification/validation documentation.
  • Broad experience with biochemistry and biological assay support, as well as generating/reviewing the documentation that supports such work.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or . – provided by DiceTracking

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