Data Integrity Analyst

MUST HAVE:

• Data integrity background
• This person will have come from a pharma background
• See more info below

Potential Job titles:

- CSV Analyst

- Validation Specialist

- QA Systems Analyst

- Compliance Specialist

- GMP Systems Analyst

- Quality Systems Specialist

- IT Compliance Analyst

Required Experience:

• Working knowledge of Computer System Validation (CSV), Data Integrity principles, and regulatory requirements for computerized systems, including 21 CFR Part 11 and EU Annex 11.
• Experience with Quality Systems such as Veeva for document authoring and Quality Management (Change Controls, Deviations, CAPAs).
• Relevant experience working with laboratory/manufacturing equipment such as Rotea, Sepax, LOVO, Cue, Prodigy, MaxCyte, Skid Controllers and platform integrations with DeltaV would be a plus.
• Relevant experience with instruments such as Spectramax, Zetasizer, MACSQuant, SoloVPE, Hamilton, BacT with MYLA software, or other similar laboratory instruments would be a plus.