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Quality Assurance Associate
Job in
Charlotte, Mecklenburg County, North Carolina, 28245, USA
Listed on 2026-10-18
Listing for:
SGS Consulting
Full Time
position Listed on 2026-10-18
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, Quality Engineering, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
- Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
- Provide QA review and approval for commissioning/qualification/validation documents.
- Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
- Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP principles including the underlying rationale of those principles.
- Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports.
- Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed.
- Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
- Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
- Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
- Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects.
- Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
- Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
- Advanced computer skills.
- Off hours coverage and flexibility may be required.
Experience:
- B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility
Position Requirements
10+ Years
work experience
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