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Sr. QC Associate, Analytical in Los Angeles, CA at APEX Systems

Date Posted: 5/15/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/15/2019

Job Description

Job #:  948398

Apex is searching for a qualified Sr. Quality Control Associate, Analytical to work at an exciting pharma company in the greater LA area!
Primary Responsibilities
  • Performs routine testing on raw materials, process intermediates, final products, stability samples and reference standards with emphasis on cell-based assay.
  • Act as SME for cell-based assay trouble shooting, investigation, protocol writing/revision, method transfer and validation.
  • Supports the qualification of a GMP compliant QC bioanalytical laboratory.
  • Participates in the validation and technical transfer of all analytical methods.
  • Authors, reviews, and approves method SOPs, stability protocols, and reference standard testing protocols, validation protocol and report.
  • Executes method validation protocols and writes validation reports.
  • Supports QC- Analytical management during internal and external inspections and audits.
  • Support nonconformance investigate, root cause analysis and implement solutions.
  • Subject to extended periods of sitting and/or standing in a laboratory environment. Ability to lift 50 lbs. and to work in BL2 laboratory required. Require handling radioactive isotope following safety guideline.

 
Position Requirements
  • Highly experienced in performing and troubleshooting on cell proliferation, cytotoxicity and other cell-based test methods.
  • Experience in analytical method qualification and validation is desired.
  • Strong independent judgment and decision-making abilities required.
  • Advanced knowledge of relevant regulations and FDA guidance is required.
  • Must possess strong organizational skills with a demonstrable ability to be self-directed while managing multiple projects.
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
  • Flexibility to work overtime, after hours and travel as required to accommodate the business needs
  • Must be able to work in controlled environments requiring special gowning for biosafety and radiation laboratories.
  • Must enjoy working in a fast paced, highly dynamic environment
  • Requires minimum a Bachelor’s Degree in Biochemistry, Molecular and Cellular Biology, Immunology, or Biology with 5 or more years of experience or an equivalent combination of education and experience.
  • Requires experience in cell-based bioassay and cell culture.
  • Quality control experience in the pharmaceutical industry supporting cGMP areas, including assay validation preferred.
  • Experience in cGMP cell therapy manufacturing and/or testing facility is a plus.
  • 5+ years experience required for a Senior Associate.

Email resumes to: bwaldron@apexsystems.com
 
 
 
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EEO Employer
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 844-463-6178-6178.