Job Description

Title: QA Equipement Data Specialist Consultant

Type of role: Contract - 20 hours/week - Part Time

Location: Emeryville, CA 94608 - Hybrid - 1-2 days onsite as needed

**** Hybrid role - Must live in the San Francisco Bay Area ****

Key Deliverables:
  1. Analyze, gather, compile all GMP equipment (asset) information required to be maintained in Blue Mountain RAM (BMRAM), to ensure completeness and accuracy:
  2. A complete GMP Equipment list representing MFG, Facility, MM, ADQC and CBA functions
  3. Equipment Metadata (ID, Location, Owner, GMP/Non-GMP, Qualification Status, PM/CAL Frequency and Due Dates, etc.)
  4. Equipment re-Classification (called Criticality in BMRAM) based on the recent SOP-EQP-025/SOP-QA-063 revision
  5. PM/CAL scheduling data
  6. Calibration Tolerance Parameter and Limits (aligned cross-functionally) per CAPA-048
  7. Vendor PM/CAL Reports and work history documentation
  8. Ensure data (from #1 above) are entered, verified, and approved by stakeholders in BMRAM such as Facility, Equipment Owners and QA.
  9. Implementation of a mechanism for managing System Periodic Review potentially utilizing BMRAM functionalities and workflows.
  10. Review and provide recommendations on how equipment information capture is optimized in relation to the onboarding process
Key requirement for the candidate:
  1. Working knowledge of GMP Equipment and Analytical Instrument qualification and maintenance processes and regulatory requirements
  2. Working knowledge of a CMMS software application such as Blue Mountain RAM (BMRAM)
  3. Fluency in MS Office tools such as Excel
  4. Strong project management and communication skills

Application Instructions

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