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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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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