Qualifications:
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
- Willingness/ability to work in a chilled environment (5 deg C)
- Standing, lifting (up to 50 lbs.), and bending are required
- Ability to work off hours and weekends
- Must be able to pass background check and drug screen.
Responsibilities:
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
| Start Time: | 8:00 AM |
| End Time: | 5:00 PM |
