GxP Compliance Specialist
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Accentuate Staffing is looking for a GxP Compliance Specialist to join a pharmaceutical company in Research Triangle Park, NC for a 6 month contract opportunity. This role will assist the Associate Director and other team members in providing quality oversight of critical cGMP activities performed internally and externally and ensure adherence to all applicable regulations and standards.
Responsibilities:
- Receive and track new vendor and/or service requests and make a GxP assessment in WinShuttle. This task may entail periodic training of Budget Managers.
- Responsible for updating and managing the master sequel lists associated with the Approved Service Provider List (ASPL). These lists contain all the vendor information that is compiled into the ASPL as well as other information about location and vendor impact levels.
- Responsible for the receipt and evaluation of Vendor Change Notifications (VCNs). Also responsible for managing VCNs in TrackWise.
- Assist in maintaining several spreadsheets used to track group activities including risk assessments, quality agreements and audit schedules.
- Assist in the development, review and revision of standard operating procedures for the GxP Compliance Department.
- Other duties as assigned
Requirements:
- Bachelor’s degree in science related field
- 3–5 years of relevant pharmaceutical industry experience in a cGMP environment, will consider a candidate with a background in supply chain or medical device.
- 3-5 years auditing experience preferred
- Proficient in Microsoft Excel
- Proficiency in Trackwise and MasterControl preferred.
- Must be able to communicate effectively, both written and orally with colleagues, management and senior management – cross-functionally. Additionally, must be able to communicate with regulatory agencies and outside vendors, when applicable.
- Working knowledge of US FDA, EU and JP GMP regulations is required.
- Must be detail oriented, self motivated, organized and have the ability to prioritize work.
- Must be able to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situations
