Specialist Quality Control

Job Title: Quality Control Specialist Duration: 10+ months Location: 27540, Holly Springs, NC Possible Extension: Yes Job Description This role is 100% on-site at the Holly Springs, NC facility, working a standard weekday schedule (8am-5pm) with some flexibility (start between 7-9am). Top 3 Must Have Skill Sets GMP; Deviation Investigation; Change Control Management The ideal candidate will bring at least 5 year of industry experience within a GMP-regulated biotech or pharmaceutical environment. Strong knowledge of quality systems and QC laboratory operations with a proven ability to write, own, and drive closure of quality records, including deviations, CAPAs, and change controls. Excellent written communication, grammar, and investigative leadership skills. Detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight. Collaboration with multiple cross-functional teams and confident leading meetings, pushing investigations independently through to completion. Experience with Veeva Quality Systems highly desirable. This position will be part of the Quality Control Deviation and Change Control team for start up. Working collaboratively with Quality Control and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System. Lead investigation teams and help to collect and report metrics for the systems team. Assist with review of validation documents to support equipment and computerized system onboarding. Author, revise and review documents and reports including SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports. Mentor new deviation owners as required. Support the startup of a GMP QC laboratory. Support routine activities over the weekends and public holidays as required. Basic Qualifications Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience. Day to Day Responsibilities Own deviation records and manage change control tasks and deliverables. Red Flags No lab experience. #J-18808-Ljbffr