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UTS - Temporary Quality Assurance Associate at UNC Chapel Hill
- Raleigh, North Carolina, United States
- Raleigh, North Carolina, United States
À propos
Position Number: 48SM71
Position Type: Temporary
Essential Job Duties
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 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
Job City & State Chapel Hill, NC
Classification Title Temporary-Service Maintenance
Working Title UTS - Temporary Quality Assurance Associate at UNC Chapel Hill
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 None
Valid NC Driver's License required? No
Commercial Driver's License Required? No
Anticipated Hiring Range $33.65 hourly
Job Open Date 06/16/2026
Quick Link https://jobs.ncsu.edu/postings/231764
EEO Statement 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.
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Compétences linguistiques
- English
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