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Remote QC Sample Management Consultant

Thousand Oaks, CA 91320

Posted: 12/04/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 592915 Is job remote?: Yes Country: United States

Job Description

The QC Sample Management Consultant position will be responsible for supporting the Quality Control team in the establishment of a robust GMP sample shipment process as well as internal sample tracking/reporting capabilities. Included in this program design is the need to incorporate a communication feedback loop with CTLs that test stability samples.  A sub-process is needed to provide a 60-day advanced notice of stability testing with CTLs to confirm they are prepared to test upcoming stability samples (staff is trained, reagents/materials are procured staged, equipment is available).  This process must include a feedback loop confirming documented acknowledgement of upcoming testing followed up with documented confirmation when sample testing has started.  Process also needs to include flexibility for shipment of raw material samples for QC testing.
The Sample Management Consultant position will interact with Quality Assurance (QA), Product Quality Lead (PQL), Supply Chain, Logistics, Translational Sciences/Process Development, and Analytical Development Teams.

Reports to                  Director, QC 
Location                     Remote
Travel:                       Travel is not likely required
Primary Responsibilities
  • Establishment of robust QC sample shipping program for QC and stability samples.  Program will include communication feedback loop mechanisms for improved coordination with CTLs.  Program requirements also include need for shipping/sample tracker that can easily indicate status of particular sample as it proceeds through sample testing process (e.g. shipping, receiving, on test, results).
  • Revision and/or creation of SOPs/Methods/Work Instructions/Forms to align with newly designed sample management process.
  • Coordinate shipment of raw materials from CMO to CTLs, as needed.
  • Attending work center team meetings and providing project updates.
  • Role model for Atara TRAIT values (Transparency, Respect, Accountability, Integrity, Trust).
Position Qualifications
  • Bachelor’s degree in relevant life science filed or supply chain/logistics field.
  • Quality control sample management experience in the pharmaceutical industry supporting cGMP areas preferred.
  • Independent decision-making capability and ability to think conceptually and understand impact of decisions.
  • Must be able to successfully work in a fast-paced environment with frequently changing priorities.
  • Must be self-motivated, be able to anticipate challenges, and identify mitigation actions.
  • Must possess excellent verbal and written communication skills; good interpersonal skills.
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