ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Perform QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.

• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices •Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.

• Manage and close CAPA investigations, Nonconformance/Deviation investigations and Compliant investigations in a timely manner.

• Generate monthly trending report for activities related to raw materials, Nonconformances, and SCARs in incoming inspection.

• Participates in the non-conformance reporting system, driving timely disposition and closure. Participate in MRB meetings.

• Identify non-conformance trends and develop and administer technical investigations and corrective action plans to resolve recurring quality problems.

• Perform and review risk assessments, participate in root cause analysis investigations and implement actions to resolve issues promptly.

• Perform and lead root cause analysis and implements corrective action as necessary. Interfaces with manufacturing for possible quality issues for new and existing customer projects.

• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.

• Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.

• Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance.

• Assist in developing inspection plans, product specifications and guide sheets.

• As needed, help in conducting the quality inspection of assigned products, parts or components.

• Participate in the assessment of returned products, incoming, in-process and final inspection.

• Assist with client and regulatory audits as required.