Administrative Coordinator - for QA Team Marietta, PA Posted: 5/24/2022
Alphanumeric is hiring an Administrative Specialist for QA Operations. This role will be onsite 100% and working with the quality team in Marietta, PA
Job Purpose: 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.
Key Responsibilities: * 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.
Knowledge/ Education / Previous Experience Required: * BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience * Minimum of 3 years pharmaceutical experience in Quality Assurance preferrably in Biologics Secondary Manufacturing or 3 years as a manufacturing technician in a Biologics Secondary Manufacturing operation * Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities. * Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required. * Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance. Working knowledge of validation principles, aseptic processing, quality systems and FDA regulations. * The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. The ability to clearly write QA documentation as necessitated by regulatory agencies and internal policies. * Able to prioritize and decide appropriate course of actions and to effectively implement decisions. * Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions