Senior Quality Assurance Specialist
Job #5335 - Senior Quality Assurance Specialist - Elkton, VA
Functional Area: Quality
The incumbent will be responsible for maintenance of cGMPs within assigned areas in conformance with Merck Policies and in compliance with Health Agency regulations and all other governing agencies. This may include ensuring cGMPs are utilized for all batch/facility cleaning documentation, change control and day-to-day operations for a bulk sterile/aseptic process. As needed reviews and approves investigations, facility/process qualification and validation studies, participates in quality audits of the manufacturing areas to ensure compliance to cGMPs. The successful candidate will also support pre-approval inspection and regulatory filing related activities. Serves as a contact for the assigned area and shares responsibility for delivery of QO support and agreed to objectives for the area as part of a QA team. This individual may also be responsible for the material control of product manufactured in the assigned area one qualified in accordance with Merck Policies and Regulatory expectations. Provides QA support to the plant including training and guidance on the interpretation and implementation of MMD guidelines/policies and regulatory requirements. This position reports to the Bulk Sterile Quality Assurance Lead.