Stability Analyst

Prokatchers LLC
 Remote

Position: Stability Analyst

Duration: 12+ months Contract (Temp to Perm)

Location: 6600 Sierra College Blvd, Rocklin, CA 95677

Shift Timings: 8:00am – 5:00pm, M-F

Job Description:

  • Under moderate supervision, the Stability Analyst will be part of the Quality team and responsible for performing stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.
  • Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS.

Essential Duties and Responsibilities:

  • Perform stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.
  • Record and document testing results accurately and per applicable regulatory and SOP requirements.
  • Data analysis using Microsoft Excel.
  • Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
  • Troubleshoot equipment problems.
  • Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
  • Maintain cGMP compliance in the laboratory.
  • Other duties as assigned or required

Additional Responsibilities:

  • Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management
  • Must be willing and able to work on weekends or extended hours as needed

Knowledge, Skills & Abilities:

  • Knowledge & experience in ELISA, bioburden and IHC testing
  • Ability to work independently and manage multiple analyses
  • Knowledge of cGMPs related to QC operations
  • Experience working in ISO 13485 and/or FDA regulated laboratory
  • Experience in SAP and/or SAP NEXT
  • Good computer skills, PC including MS Excel
  • Excellent written and verbal skills
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