QA Validation Specialist
Job in
Winston-Salem, Forsyth County, North Carolina, 27104, USA
Listed on 2026-09-28
Listing for:
Akaasa Technologies
Full Time
position Listed on 2026-09-28
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager -
Pharmaceutical
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Local Candidates Only (Commute Not to Exceed 60 Miles/60 Minutes)
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 Life Sciences, Engineering, or related field
- 3+ years Validation experience in a Pharmaceutical/GMP environment
- Experience developing/reviewing/executing IQ/OQ/PQ protocols
- Equipment, Utilities, and Process Validation experience
- Strong knowledge of FDA, EMA, ICH, GAMP5
- Risk-Based Validation experience
- Validation Lifecycle Management experience
- Data Integrity knowledge
- Deviation Investigations & CAPA experience
- Validation Documentation experience
- Cross-functional collaboration with QA, QC, Engineering & Manufacturing
Strong Pluses:
- Veeva Vault
- SAP
- PAS-X
- Computer System Validation (CSV)
- CSA/Data Integrity requirements
- LEAN / Kaizen / Root Cause Analysis
- FMEA / HACCP Risk Assessments
Ideal Candidate Profile: Hands-on pharmaceutical validation professional with experience supporting equipment, utilities, process validation, IQ/OQ/PQ execution, deviation investigations, CAPAs, and maintaining validated GMP systems.
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