Job description
Alphanumeric is urgently hiring a Pharma Manufacturing
QA Assoc. - Level 1 to work 2nd shift 3 pm - 11:30 pm in Marietta, PA, we also have a 1st shift 8 am - 4:30 pm role available with our Global Pharmaceutical client working a 40-hour week Mon-Fri on an initial 1-year contract basis.
The QA Operations Specialist provides a link between operations and the various quality systems. Primary responsibility is to directly support operations and validation projects that require quality oversight.
Key Responsibilities:
- Perform technical review of cGMP documentation, including change controls and validation documents, for completeness and compliance with cGMPs as outlined by governmental regulations and internal procedures.
- Ability to work with a cross-functional team in a fast-paced environment
- 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 the QA review of associated processes. This includes deviation investigations, customer complaint investigations, etc
- Alert management of production trends which may serve as a 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
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