1 MQA Specialist I Job in Bristol, TN

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MQA Specialist I

UPM Pharmaceuticals

Bristol, TN | Full Time

$81k-103k (estimate)

6 Months Ago

MQA Specialist I

$81k-103k (estimate)

Full Time | Wholesale 6 Months Ago

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UPM Pharmaceuticals is Hiring a MQA Specialist I Near Bristol, TN

Ensures that manufacturing and packaging operations conform to established standards and specifications. Participates in batch record review and evaluation, evaluation of product trends, daily monitoring of manufacturing operations, and audits as assigned.

Essential Duties and Responsibilites

Becomes proficient in the manufacturing operations and quality procedures for the area (s) to facilitate compliance to regulations.

Assists and supports the manufacturing/packaging/laboratory staff in detecting and solving compliance errors in real time during operations.

Participates in understanding failures and resulting corrective and preventative actions (CAPAs) through notice of event reports.

Assign disposition to bulk, intermediate, finished product and components based on batch record review for compliance to the current Good Manufacturing Practices, compendia standards, and company specifications. This activity provides authorization for the transfer or use of product or components at significant evaluation points in the manufacturing process and ultimately for the release to distribution. It involves review of the batch record for the completeness and accuracy of entries, adequacy of investigation of deviations and conformance to test results with the established standards.

Evaluate and approve in-process data in accordance with the established specifications to measure conformance of final container contents to label claim.

Reports to management any observed NOEs for procedural deviations.

Evaluates information from attribute inspections, assigns appropriate corrective actions to failed inspections, and follows up on corrections.

Participates in, or responds to, quality audits when applicable to assure conformance with regulatory and internal requirements.

Revises, evaluates, and approves SOPs, MBRs as necessary.

Compile Annual Product Reviews for the commercial market and evaluate stability data and trends; identify any preventative or corrective actions that would lead to product quality improvements and report them to upper management.

Participate in customer complaint investigations, as necessary.

Other duties as may be assigned.

Education/Experience:

Bachelor's degree in a technical field, i.e., Biology, Chemistry, Engineering, or Pharmacy and 0-2 years of related experience and/or training; or equivalent combination of education and experience.

To apply, send resume and salary requirements to:
humanresources@upm-inc.com