Quality Specialist

Akaasa Technologies

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 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.

Apply

Vacancy posted 2 days ago

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