UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

Posting Details Position Information Posting Number

PG196058TM

Position Number 48SM71 Position Type Temporary Essential Job Duties As a temporary QA Specialist, your daily responsibilities will include, but are not limited to, the following areas:

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. Is Time Limited Yes If Yes, Appointment Length TBD Wolfpack Perks and Benefits As a Pack member, you belong here , and can enjoy exclusive perks designed to enhance your personal and professional well-being. As you consider this opportunity, we encourage you to review our Employee Value Proposition and learn more about what makes NC State the best place to learn and work for everyone.

What we offer:

Health Insurance for Temporary Employees Enhance your career with LEAD courses Attend non-revenue generating sporting events for free. Attain Work-life balance with our Childcare discounts , Wellness & Recreation Membership , and Wellness Programs that aim to build a thriving wolfpack community.

Disclaimer:

Perks and Benefit eligibility is based on Part-Time or Full-Time Employment status. Eligibility and Employer Sponsored Plans can be found within each of the links offered. Department Information Job City & State Chapel Hill, NC Department System Information Classification Title Temporary-Service Maintenance Working Title UTS - Temporary Quality Assurance Associate at UNC Chapel Hill Position Information Requirements and Preferences Work Schedule Monday-Friday, 8:00 AM-5:00 PM Other Work/Responsibilities Other duties as needed.

Minimum Experience/Education 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.

Department Required Skills 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 MasterControl 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.

Preferred Years Experience, Skills, Training, Education Industry Specifics:

Prior experience working specifically within cellular therapy, biologics, or blood banking facilities.

System Expertise:

Direct, hands-on experience utilizing MasterControl or a similar electronic Quality Management System (eQMS).

Validation Knowledge:

Experience overseeing or reviewing validation protocols and executed work packages against an established project plan.

Advanced Technical Writing:

Experience leading root-cause analysis investigations and authoring Corrective and Preventive Action ( CAPA ) plans.

Continuous Improvement:

Familiarity tracking manufacturing errors and analyzing metrics to support corporate Key Performance Indicators (KPIs). Required License or Certification N/A Valid NC Driver's License required? No Commercial Driver's License Required? No Recruitment Recruitment Details Anticipated Hiring Range $33.65/hourly Recruitment Dates Job Open Date 06/16/2026 Applicant Information Quick Link https://jobs.ncsu.edu/postings/231764 EEO NC State University is an equal opportunity employer. All qualified applicants will receive equal opportunities for employment without regard to age, color, disability, gender identity, genetic information, national origin, race, religion, sex (including pregnancy), sexual orientation, and veteran status. The University encourages all qualified applicants, including protected veterans and individuals with disabilities, to apply. Individuals with disabilities requiring disability-related accommodations in the application and interview process are welcome to contact 919-513-0574 to speak with a representative of the Office of Equal Opportunity. If you have general questions about the application process, you may contact Human Resources at (919) 515-2135 or workatncstate@ncsu.edu. Final candidates are subject to criminal & sex offender background checks. Some vacancies also require credit or motor vehicle checks. Degree(s) must be obtained prior to start date in order to meet qualifications and receive credit. NC State University participates in E-Verify. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. Supplemental Questions Required fields are indicated with an asterisk (

• ).

• How did you hear about UTS? (Open Ended Question)
• Do you have direct, hands-on experience utilizing MasterControl or a similar electronic Quality Management System (eQMS)? Yes No
• Briefly describe your experience with batch record review and document control.

(Open Ended Question) Applicant Documents Required Documents Resume Contact Information for References Optional Documents Cover Letter