Regulatory Compliance Expert
2 weeks ago
This is a vital position that requires a Quality Assurance Analyst to provide oversight and ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
Key Responsibilities- Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
- Perform review and approval of cGMP processes, procedures, documents and records, including logbooks, batch records, attachments, work orders, and other GMP documentation.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alert management of quality, compliance, supply and safety risks, and complete required assigned training to permit execution of required tasks.
- Work in a clean room space for the majority of the time on shift, including gowning in and out of frocks and coveralls.
- Communicate and collaborate with the PQA shift to ensure required tasks are completed.
- Bachelor's Degree and 4 years of Quality/Manufacturing experience.
- cGMP Experience.
- Excellent written and verbal communication skills.
- Experience with decision making.
- Manufacturing
- cGMP
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