QA Specialist

The Quality Assurance Specialist is responsible for the daily Quality Assurance support in the Manufacturing and Packaging processes on-site as well as all Quality Assurance processes related to CMO. In this role, the QA Specialist will support the Quality Department and Manufacturing through process improvements, non-conformance investigation and other GMP functions; this position requires the QA Specialist to be flexible to support QA and business operations as needed.

Roles and Responsibilities:

· Provide In-process Review and Training to production operators.

· Understand the roles and responsibilities of the Contract Manufacturing Organizations.

· Assisting with trending and developing metrics through QA department.

· Assisting Qualityze functions.

· Familiarity with QA Functions in SAP.

· Creating / Revising process changes, SOPs, batch records, and other GMP functions.

· Perform Non-conformance investigations.

· Monitor the status of NCRs and CAPAs for completion and reoccurrences.

· Review and release of CMO batch records and assist with in house batch release.

· Will assist in the correction of deficiencies found within the documentation review per cGMP, Nutramax SOPs, Contract Manufacturing Organization (SOPs), and Global Regulations criterion.

· Must be able to effectively communicate with other departments and function within a team environment.

· Perform other assigned duties as may be required in meeting company objectives.

· Regular attendance is required.