Quality Specialist

Quality Specialist – Change Control Management

Location: Wilson, NC 27893 (4700 International Blvd. West, Wilson, NC)

Onsite: Local Candidates Only (Commute Not to Exceed 60 Miles/60 Minutes)

Final Interview: Mandatory Onsite Interview

Duration: 12-Month Contract

Nearby ZIP Codes: 27893 (Wilson), 27896 (Wilson), 27822 (Elm City), 27883 (Stantonsburg), 27880 (Sims), 27851 (Lucama), 27804 (Rocky Mount), 27803 (Rocky Mount), 27542 (Kenly), 27557 (Middlesex), 27597 (Zebulon)

Quick Capture Requirements

Must Have:

• Bachelor's Degree in Scientific Discipline, Engineering, Biology, Chemistry, Microbiology, or related field

• 3-5+ years Quality Assurance experience in Pharmaceutical/Biotech/Medical Device environment

• 2-3+ years direct Change Control Management experience

• Experience managing full Change Control lifecycle

• Strong cGMP knowledge

• FDA regulations experience

• ICH Q7, Q9, and Q10 knowledge

• Risk Assessment experience (FMEA, Risk Ranking, Risk Assessments)

• Validation & Qualification knowledge

• Deviation & CAPA experience

• Electronic Quality Management Systems (eQMS)

Preferred Systems Experience:

• Veeva Vault (Highly Preferred)

• TrackWise

• MasterControl

• ComplianceWire

Strong Pluses:

• Regulatory Inspection Support

• CSV (Computer System Validation)

• Annex 11

• Data Integrity (ALCOA+)

• Oral Solid Dosage Manufacturing

• Lean Six Sigma

• ASQ/CQA Certification

Ideal Candidate Profile: QA professional with pharmaceutical Change Control expertise who has managed GMP changes from initiation through closure while partnering closely with Manufacturing, Engineering, Validation, Regulatory Affairs, and Quality teams.