Quality Assurance Associate

SGS Consulting
North Carolina

Job Responsibilities:

  • 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.

Skills:

  • 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.

Education/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
Posted 2025-11-14

Recommended Jobs

Service Technician

Hi - Line Autohaus
Charlotte, NC

Join the Legacy of Excellence in 2026 at Hi-Line Autohaus At Hi-Line Autohaus, we’re more than just a dealership — we’re a locally owned, family-run business with a passion for performance, precisio…

View Details
Posted 2025-10-21

Senior Subcontract Administrator (LSNA-NC)

Cary, NC

Life Science At Jacobs, we're challenging today to reinvent tomorrow by solving the world's most critical problems …

View Details
Posted 2026-02-24

CL A Hazmat & Tanker Drivers Run Cryogenic Avg 1925/WK

Wick TR
Raleigh, NC

Class A Drivers – Cryogenic Regional Projects $85,000–$100,000+ Annually Are you ready to join a world-class cryogenic carrier with consistent, high-paying regional work? We are seeking skilled Cla…

View Details
Posted 2026-02-14

Medical Assistant Bilingual Preferred

Ortho Sport and Spine Physicians
Greenville, NC

Ortho Sport & Spine Physicians is a nationally recognized center of excellence in orthopedic sports medicine, orthopedic spine surgery, and interventional spine treatments. We have locations through…

View Details
Posted 2026-02-16

Fall 2026 Preconstruction Co-op

McKenney's Inc.
Charlotte, NC

JOB SUMMARY As a Co-op, you will be part of the team from day one and given training and tasks that are important and impactful to our projects' success. Success in this role depends on the Co-…

View Details
Posted 2026-01-15

Family Medicine/OB Physician - Roanoke Rapids, NC (90 Minutes to Raleigh & Richmond, VA) - 3541553

Roanoke Rapids, NC

Family Medicine/OB Physician – Roanoke Rapids, NC (90 Minutes to Raleigh & Richmond, VA) Seeking an experienced BC/BE Family Medicine/OB fellowship training to join a growing women’s health pract…

View Details
Posted 2026-02-14

Executive Director, QMS AI Quality & Compliance- fully remote!

Thermo Fisher Scientific
North Carolina

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to workin…

View Details
Posted 2026-02-24

Remote Client Services Associate

Blyss Journeys
Greensboro, NC

We are seeking a Client Services Associate to provide reliable, thoughtful support to clients by assisting with coordination, communication, and ongoing service needs. This role is centered on orga…

View Details
Posted 2026-02-01

Machine Operator

Trinity Road, LLC
Charlotte, NC

Position Summary: The Machine Operator is responsible for setting up, maintaining, and operating different pieces of equipment and meeting daily productivity goals, safety, and quality standards. The …

View Details
Posted 2026-01-19

Administrative Assistant

Carter Lumber
Sanford, NC

A Carter Lumber Administrative Assistant is responsible for providing administrative support which includes financial reporting, bookkeeping, accounts payable and accounts receivable.  Ensures that t…

View Details
Posted 2026-02-24