OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Quality Assurance Coordinator in Calyton, North Carolina. The Quality Assurance Coordinator will be responsible for managing workflows and reviewing change control documentation within an electronic Quality Management System (eQMS), ensuring compliance with cGMP standards and internal procedures. Their work will have a direct impact on quality operations, regulatory compliance, and production readiness, making this an excellent career opportunity.

RESPONSIBILITIES
•    Manage workflow and review of change control records within an electronic Quality Management System (e.g., Veeva) 
•    Review change control documentation for accuracy, completeness, and compliance with cGMPs and applicable standards 
•    Track, monitor, and follow up on open change control records and associated action items 
•    Generate routine reports on the status and progress of change controls and key performance indicators (KPIs) 
•    Issue production work orders and support orders as required 
•    Coordinate and follow up on change control activities related to shutdown projects, including authorization for return to production and product release 
•    Issue and manage equipment/facility tag-outs as required by change control processes 
•    Process and maintain controlled documents within the Document Management System, including workflows for review, approval, issuance, and effectiveness 
•    Support projects related to document management systems and change control improvements 
•    Utilize tools such as Microsoft Excel, Access, and eQMS systems for tracking, trending, and reporting 
•    Communicate effectively with cross-functional teams to ensure timely completion of tasks and provide excellent internal customer service 

EXPERIENCE
Minimum of 2+ years of experience in a quality systems, document control, or change control role required
Experience in a cGMP-regulated environment strongly preferred
Hands-on experience with electronic Quality Management Systems (eQMS), such as Veeva, highly desirable
Experience with document management systems and workflow processes required
Experience with data tracking, reporting, and KPI generation preferred

EDUCATION
Minimum of a Bachelor’s Degree in a scientific, technical, or related discipline required
(Advanced degree may be considered in lieu of experience; equivalent work experience also considered)

To be a best-fit your strengths must include:
•    Strong understanding of cGMP regulations and quality systems processes 
•    Excellent attention to detail with the ability to maintain accurate and complete records 
•    Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment 
•    Analytical thinking and structured problem-solving abilities 
•    Proactive, self-starter mindset with the ability to work independently and as part of a team 
•    Effective communication skills, both written and verbal 
•    Strong interpersonal skills with the ability to collaborate across all levels of the organization 
•    Proficiency in Microsoft Office tools (Excel, Word, Outlook, Access) and data tracking systems 
•    Ability to manage deadlines and adapt to changing priorities

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].

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