QC Associate - GMP, bulk testing in Fremont, CA at Apex Life Sciences

Date Posted: 11/16/2018

Job Snapshot

Job Description


Responsibilities

  • Executes and coordinates routine and non-routine testing in QC of bulk drug substance and drug product in a multi-product facility.
  • Executes independently with adequate training fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolalilty
  • Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.  Delivery of high quality analytical results within timeline right the first time
  • Documents work according to cGMP and cGDP.  Adheres to established regulations and follows cGMP established by site. Reports abnormalities and deviations in a timely and accurate manner.
  • Adheres to safety standards and identifies unsafe situations / habits and escalates approriately. Maintains work production areas according to predefined standards (5s).
  • Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification.
  • Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments

Qualifications

  • Bachelors' degree in Biology or Life Sciences required
  • 3-5 years of industry experience
  • GMP experience is highly prefered
  • Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
  • Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals.
  • Demonstrates strong attention to detail, and an ability to focus on details of execution

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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