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Senior Quality Assurance Specialist

Job #5335 - Senior Quality Assurance Specialist - Elkton, VA Job Description Functional Area: Quality Duties: 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. Qualifications: Bachelor's Degree in a science related field or experience in Quality Assurance Role or Qualification support role in sterile or aseptic area. Communication and decision making skills: Ability to communicate with all levels of site and MMD organizations through all means (written, verbal, presentations, etc.). Strong decision making skills. Minimum 3 years of experience in a facility that is highly regulated in a Quality Operations or Technical Operations or Manufacturing role or similar experience. Ability to work with and interact with off-site customers. Demonstrated experience in these areas: Detailed knowledge of sterile or aseptic operations. Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends. Demonstrated knowledge of Quality systems. Experience interacting with Health Agency inspectors. Competency in use of current MMD or similar industry enterprise resource management system for control of product.

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