Quality Control - Stability Specialist I or II

San Francisco, CA 94104

Posted: 07/14/2020 Employment Type: Contract Industry: Clinical & Scientific Job Number: 17655

Job Description


Stability Specialist I or II, QC

Description:

Seeking a Stability Specialist Temporary to join the Quality Control group. The QC Stability Specialist Temporary will be responsible for QC stability program; organization stability studies, management of stability inventory, and stability chambers/equipment, as well as assist with general lab testing. The Specialist will also support sample management and as appropriate, document management and revision. This role will be reporting to the Manager, QC Sample Management and Stability and will be located in our South San Francisco Quality laboratories.
Primary Responsibilities

  • Initiate new stability study configuration documents
  • Update Excel files with all new stability study information, manage Excel files to indicate completion of sample testing
  • Manage stability inventory, stability schedule, pull samples from storage condition(s)
  • Aliquot and label samples, distribute to testing labs, ensure proper storage of samples
  • Ship samples to external contract labs, as required
  • Perform some stability testing as required or commensurate with experience Color, Clarity, Visible Particulates, pH, Osmolality
  • Interact with Analytical Development, QC Analytical and QC Microbiology teams to ensure timely testing of samples according to protocol
  • Stability data management: collect stability data and create/update stability tables using templates, scan data and put in proper folders, review/manage stability logbooks
  • Submit stability tables to Master Control or other EDMS for collaboration and approvals
  • Help with trending of stability data
  • Lead or participate stability deviations: invalid results, unexpected results, OOS/OOT, lab investigations, and contract lab discrepancies
  • Perform stability document revisions and document management
  • Ensure lab compliance with applicable cGMP regulations and SOPs, and support regulatory audits

Must Have/Required
  • B.S. degree in biological sciences, cell biology, chemistry or related field with 1-2+ years of laboratory or stability experience
  • Good to excellent technical writing skills and verbal communication skills
  • Excels in a fast-paced team environment, handles multiple tasks concurrently, and in a timely fashion
  • Strong interpersonal skills, highly collaborative within a multi-discipline team and contributes to a supportive and positive work environment
  • Highly self-motivated and goal oriented
  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.
  • Must be willing to work second shift, rotating shifts, overtime, weekends and holidays, as required

May Have/Preferred
  • Prior laboratory experience
  • Prior GMP environment experience
  • Knowledge of Good Document Practices (GDP)
  • Demonstrated proficiency in Microsoft Office suite

 

 

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Neyba Soto

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