UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

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Department: 480502 - UHR UTS/UNC Partnership

Location: Chapel Hill, NC

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.

Other Work/Responsibilities:

Other duties as needed.

Required Qualifications:

• 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 Qualifications:

• 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

Position Number: 48SM71

AA/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 View phone number on click.appcast.io 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 View phone number on click.appcast.io or View email address on click.appcast.io.

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.