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Quality Assurance Specialist

2 months ago


indianapolis, United States Integrated Resources, Inc ( IRI ) Full time

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