Quality Systems Specialist

Quality Systems Specialist

We are seeking a dedicated and experienced Quality Systems Specialist to join our team at a facility in Holly Springs, NC. This full-time, on-site position offers a standard weekday schedule from 8am to 5pm, with some flexibility to start between 7am and 9am. The ideal candidate will have extensive experience in a GMP-regulated biotech or pharmaceutical environment and a strong understanding of quality systems and QC laboratory operations.

Responsibilities

• Collaborate with Quality Control and Quality Assurance teams to author and own change control records and deviations in the DQMS Veeva System.
• Lead investigation teams, collect, and report metrics for the systems team.
• Assist with the 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, and 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.

Essential Skills

• At least 5 years of industry experience in a GMP-regulated biotech or pharmaceutical environment.
• 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.
• Confident in leading meetings and pushing investigations independently through to completion.

Additional Skills & Qualifications

• Experience with Veeva Quality Systems is highly desirable.
• Doctorate degree or Masters degree with 2 years of experience, or Bachelors degree with 4 years of experience, or Associates degree with 8 years of experience, or High school diploma / GED with 10 years of experience.

Work Environment

This position is 100% on-site at the Holly Springs, NC facility. Employees will work a standard weekday schedule from 8am to 5pm, with some flexibility to start between 7am and 9am. The role involves collaboration with cross-functional teams and requires proactive engagement in a dynamic, fast-paced environment.

Job Type & Location

This is a Contract position based out of Holly Springs, NC.

Pay and Benefits

The pay range for this position is $40.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Holly Springs,NC.

Application Deadline

This position is anticipated to close on Jul 30, 2026.