The successful candidate will be responsible for the coordination and management of GMP documentation activities supporting Revance’s manufacturing operations. This position requires close collaboration with the Process Sciences, Quality Control (QC), and Quality Assurance (QA) groups to ensure that all documentation activities are completed within the required timelines. A successful applicant in this position should have flexibility, good organization, excellent time and project management skills, good interpersonal skills and work with minimal supervision.
• Creation and revision of Manufacturing documentation including Batch Records, Standard Operating Procedures, Materials Specifications and Protocols/Reports.
• Participate and support internal and external audits and coordinate completion of audit responses within applicable deadlines.
• Monitor internal schedules for manufacturing campaigns and schedule batch related activities with Quality and other support groups.
• Review of completed batch records and other GMP documents in collaboration with Quality Assurance as needed to ensure accuracy and completion in accordance with cGMP regulations.
• Development and coordination of training sessions for new and existing SOPs and Batch Records in collaboration with Process Sciences and Quality groups.
• Other duties as assigned in support of Manufacturing Team.
• Working knowledge of cGMPs for biopharmaceuticals, excellent communication skills, an ability to work effectively with others in a dynamic environment.
• BS in Biological Sciences, Chemistry or related discipline and 1-2 years of experience in a GMP environment.
Preferred Additional Skills (i.e., Computer):
• Proficiency in MS Office (Word, Excel, Vizio Project etc.) software.