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Scientific. Clinical. Software Engineering

QA Specialist

Raleigh Metro Area, NC

Job Type: Scientific Job Number: JN -052020-26792 Region: Raleigh Metro Area

Job Description


Collates shipping and receiving documents per batch. Reviews and approves transportation data and recommends disposition of vaccine products for in-country distribution (CFDs).

Partners with Customer Services, Operations and Warehouse partners on the investigation and approval of Customer Initiated Discrepancies (CIDRs).

Assists with tracking incoming PTC samples and shipment of those samples to manufacturing sites.

Performs reviews of customer temperature excursions and recommends disposition for product to end user customers based on Time out of Refrigeration studies.

Assists in the review/revision/routing of Standard Operating Procedures and Quality Agreements and other GxP documents as necessary

Supports other QA activities and projects, as needed


The role holder needs to be able to work with limited supervision and with multinational teams. A good understanding of the requirements for the design and validation of robust temperature-controlled shipping solutions together with the ability to assess deviations and make compliant recommendations for product disposition is essential for the role


Bachelor s Degree in relevant business or science discipline strongly preferred, or equivalent experience.

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