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