The contractor for Data Integrity will execute data management/integrity activities across PR&D including document and record issuance and reconciliation. As part of the quality unit, this role is responsible for ensuring compliance with all applicable procedures across PR&D with a focus on data integrity and document and records management. This role will include a mix of desk-based work and visits to regulated areas including labs, production, and warehouse areas. Tasks include, but are not limited to:
• Issuance and reconciliation of GMP documents from document repositories following approved procedures.
• Accountable for maintenance of physical documentation in GMP areas.
• Perform Good Documentation Practices reviews of GMP documentation, as needed.
• Execution of audit trail reviews within computer systems following approved instructions.
• Execution and documentation of quality checks following approved procedures.
• Data entry into computer systems as required.
• Perform other duties as required.
SHIFT: Monday- Friday, 8 hours/day on-site attendance required. Ability to work shifts as needed (morning, afternoon based on future business needs)
Safety Equipment Required: Steel toes shoes or gowning as appropriate.
Quals--
Associate Degree or equivalent work experience.
• Relevant industry experience in Quality Assurance, Quality Control, Operations, Engineering or Technical Services.
• Basic computer skills including Microsoft Office, TrackWise, Veeva Quality Docs and web-based applications
