QA Specialist
astekRaleigh, NC
QA Specialist
L5
astekRaleigh, NC3 days ago
Occupations
Quality Control AnalystsQuality Control Systems ManagersInspectors, Testers, Sorters, Samplers, and WeighersIndustries
Pharmaceutical Preparation ManufacturingBiological Product (except Diagnostic) ManufacturingResearch and Development in Biotechnology (except Nanobiotechnology)QA Specialist - Zebulon, NC (On-site) We are hiring a QA Specialist to join a global pharmaceutical organization at its Zebulon, NC facility, supporting the quality and compliance of Investigational Medicinal Products distributed worldwide. This is a full-time, on-site position (first shift, 8:00 am to 5:00 pm).
Key Responsibilities:
- Serve as Batch Release Officer, reviewing and recommending release of documentation for dosage form batches and finished clinical trial packs, in line with GMP requirements
- Assess Quality QMS records (deviations, internal and third-party complaints) and recommend corrective and preventive actions
- Review and approve GMP documentation (SOPs, Change Controls, and other controlled documents) from business partner areas such as Clinical Supply Chain packaging and logistics
- Provide quality-related advice and support to business partner areas
- Contribute to the development of processes and procedures within Quality R&D Supply QA/QP USParticipate in audits/assessments, regulatory inspections, and high-priority projects
- Lead or contribute to continuous improvement initiatives
Required:
- Bachelor's degree or equivalent experience (5+ years in a similar role)QA review experience with GMP manufacturing/packaging documentation and/or laboratory records for pharmaceutical dosage forms (sterile products a plus)
- Solid working knowledge of GMP principles, with proven decision-making based on this knowledge
- Experience leading or participating in QMS activities (deviations, complaints, change controls, inspections/audits, root cause analysis)
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
Preferred:
- Experience working in high-pressure environments with competing priorities
- Knowledge of R&D processes, particularly clinical trials manufacturing and packaging
- Strong attention to detail
- Excellent communication skills and ability to build trust-based relationships
Apply now
Level
SeniorL5
Location
Raleigh, NC
Occupation
Quality Control Analysts
Industry
Pharmaceutical Preparation Manufacturing
Posted
3 days ago
To get sharper similar jobs, create your profile using the link below.