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.
• They must demonstrate 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.
• This role requires excellent written communication, grammar, and investigative leadership skills. Candidates should be detail-oriented, proactive, and able to navigate shifting priorities in a fast-paced environment with minimal oversight.
• They will collaborate with multiple cross-functional teams and should be confident leading meetings and pushing investigations independently through to completion.
• Experience with Veeva Quality Systems is 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.
• Individual will lead investigation teams and help to collect and report metrics for the systems team.
• Individual may assist with review of validation documents to support equipment and computerized system onboarding.
• Individual may author, revise and review documents and reports including but not limited to SOPs, test methods, safety assessments, trend reports, qualification/validation summary reports, technical reports.
• Individual will 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