Alphanumeric is hiring a QA Operations Specialist to work in Marietta, PA with one of the largest pharmaceutical companies in the world.
The QA Operations Specialist provides a link between operations and the various quality systems. Primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval.
* Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
* Provide advice and counsel on cGMP and related quality assurance issues to the value stream
* Demonstrate sound decision making relating to quality issues
* Provide on the floor QA support and perform QA Operations activities (batch record review and issuance, room release, line clearance, documentation review etc)
* Take initiative to resolve quality documentation concerns (e.g., investigations, deviations, change controls, and other required documentation).
* Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, et al.
* Alert management of production trends which may serve as forewarning of process or equipment problems. As necessary, initiate CAPA investigations to address these issues.
* Write and/or revise controlled documents in support of job responsibilities.
* Routinely communicate and report deviations from procedures/processes to Quality Assurance Management and initiate appropriate action as necessary.
* Ensure all GMPs, validation, quality, safety and environmental regulations are met. Adhere to all safety guidelines and procedures.
This position requires that all workers be fully vaccinated against COVID-19 and proof of vaccination will be required. Considerations will be made for those seeking Medical Exemption under ADA or Religious exemption under Title VII