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QA Specialist

Alphanumeric Systems, Inc.

QA Specialist

Marietta, PA
Full Time
Paid
  • Responsibilities

    Job Description

    Alphanumeric is hiring a QA SPECIALIST

    • Level 1 to work in Marietta, PA with one of the largest pharmaceutical companies in the world. Key : -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. Key Skills/Education/Experience: BS/BA in biology, chemical engineering, life sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience. QA experience preferred. Minimum 1 year also preferred.

    Company Description

    At Alphanumeric, we believe that no matter how great your vision, it's your people—customers and employees—that will it a reality. Since 1979 we've helped our pharma, healthcare, public sector, and finance clients realize their vision by removing the friction from customer and employee experience. Our large-scale contact centers feature artificial intelligence and deep expertise—achieving customer satisfaction ratings upwards of 95 percent. We offer fully managed technology modernization, security, and support across your entire workforce. When it comes to employees, we know that technology and operations are only half of the story; our learning solutions help you swiftly and effectively on-board, ensure compliance, and transform your workforce. Improving people experience is what we do, but the thing that really gets us fired up is our relationship with our customers.