Qc Assoc I in South San Francisco, CA at Apex Life Sciences

Date Posted: 8/30/2018

Job Snapshot

Job Description


Apex Life Sciences is looking to hire a QC Associate with a large Biotech company South San Francisco. The primary duties for this role are performing biochemical and analytical lot testing of raw materials, commercial and clinical fermentation, purification, and final product samples to meet standard lead times.

Education Requirements: BS degree in Microbiology, Chemistry, Biology or related field

Duties:

  • Review data and assess against established acceptance criteria.
  • Order lab supplies and maintain inventory.
  • Identify discrepancies, participate in quality investigations and CAPA initiatives as needed.
  • Prepare and maintain standards, controls, stocks, and cultures per established protocols.
  • Support the maintenance and compliance of operational areas. Assure strict adherence to cGMPs throughout operation.
  • Ensure training qualifications are up to date. Identify and support resolution of technical problems.
  • Perform SWAT and routine maintenance duties to ensure inspection ready state.
  • Additionally participate in assay, facility, equipment and process validation. Perform equipment qualification and maintenance activities.
  • Actively participate in group and project teamwork; project and process improvements.
  • Draft protocols and reports under supervision.
  • Work with internal and external groups to develop methods for clinical products for in process and final products testing.

Skills: 

  • BS degree in Microbiology, Chemistry, Biology or related field and a minimum of 2 years relevant experience in the bio/pharmaceutical industry.
  • Experience in the conduction of chemistry assays such as TOC, UV Spectrometry, pH and HPLC is a plus.
  • Sound knowledge of cGMPs or equivalent regulations. Experience using basic computer software (Word, Excel, and PowerPoint).
  • Working knowledge of SAP, Labware LIMS and Livelink a plus.
  • Ability to communicate clearly and professionally in writing and verbally.
  • Basic knowledge of scientific theories, principles and techniques used in biological or analytical test procedures.
  • Ability to exercise sound judgment, reasoning and problem solving.
  • Ability to work off-shift, weekends and holidays as needed.
  • Must be physically able to perform the following tasks: Work in a laboratory environment including biosafety cabinets.
  • Able to lift up to 25lbs.
  • Sit, stand and move within work space for extended periods.

Hours Per Day: 8.00

Shift: The shift for this position is Thursday-Sunday, day shift (4 days, 10 hours/day, 0630-1700)

Please send your resumes to awoods@apexlifesciences.com

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.




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