UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

Posting Details

Posting Number: PG196058TM

Position Number: 48SM71

Position Type: Temporary

• Quality Systems & Guidance: Provide direction and set clear expectations for ACT facility employees regarding the execution of quality processes.
• Document Control: Help manage the critical document control system. Ensure all facility documents are revised, made effective, and archived in a controlled manner.
• Batch Record Management: Assist in the creation and issuance of batch records and required process forms. Complete initial reviews of executed batch records, identify necessary corrections, and collaborate with teams to resolve issues.
• Deviations & CAPA: Initiate and investigate deviations related to manufacturing and product release. Identify effective Corrective and Preventive Actions (CAPA) to improve overall processes.
• Validation Support: Direct others executing validation work, review completed work, and ensure all tasks align with the established plan.
• Metrics & KPIs: Track QA system progress through internal auditing and tracking/trending manufacturing errors to support Key Performance Indicators (KPIs).
• Material Release: Inspect incoming materials to ensure they meet all technical specifications for manufacturing use.
• Technical Writing: Act as a writer and resource for policies, Standard Operating Procedures (SOPs), forms, worksheets, and job aids.
• Collaboration & Training: Serve as a liaison for manufacturing projects and assist in training other QA/QC team members on quality systems.

Yes

TBD

The following benefits are available to temporary employees:

• Health Insurance for Temporary Employees
• Enhance your career with LEAD courses
• Attend non-revenue generating sporting events for free
• Childcare discounts
• Wellness & Recreation Membership
• Wellness Programs

Chapel Hill, NC

Temporary-Service Maintenance

UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

Monday–Friday, 8:00 AM–5:00 PM

Other duties as needed.

• Education: A Bachelor of Science degree in Biology, Chemistry, Bioengineering, or a related scientific discipline; equivalent industry experience will be considered.
• Experience: A minimum of two to three years of experience working within a Quality Assurance or Quality Control role inside a regulated manufacturing environment (such as Good Manufacturing Practices / GMP).
• Core
  
  Skills:
  
  Demonstrated experience with initial batch record review, document control processes, and standard technical writing (including standard operating procedures and worksheets).
• Investigation Aptitude: Proven experience initiating and documenting deviations or non-conformances within a production setting.
• Compliance: Ability to complete necessary Environmental Health and Safety (EHS) modules and maintain strictly mandated annual competencies.

• Experience: Proven experience in a Quality Assurance or Quality Control role within a regulated manufacturing environment (experience in cellular therapy is highly valued).
• Technical
  
  Skills:
  
  Proficient with Electronic Quality Management Systems (eQMS). Experience with Master Control is highly beneficial.
• Core Competencies: Strong technical writing skills, exceptional attention to detail, and the ability to investigate root causes effectively.
• Compliance: Ability to maintain annual competencies in required quality functions and remain current with Environment, Health, and Safety (EHS) Learning Management System (LMS) modules.
• Professional Development: Willingness to participate in a minimum of five hours of continuing education annually in cellular therapy or quality topics.

• Industry Specifics: Prior experience working specifically within cellular therapy, biologics, or blood banking facilities.
• System Expertise: Direct, hands-on experience utilizing Master Control or a similar electronic Quality Management System (eQMS).
• Validation Knowledge: Experience overseeing or reviewing validation protocols and executed work…