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  • Emplois similaires à : Quality Assurance Associate-Temporary
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UTS - Temporary Quality Assurance Associate at UNC Chapel HillNorth Carolina State University • Raleigh, North Carolina, United States
Postuler Maintenant
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UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

North Carolina State University
  • US
    Raleigh, North Carolina, United States
  • US
    Raleigh, North Carolina, United States
Postuler Maintenant

À propos

Essential Job Duties
Provide direction and set clear expectations for ACT facility employees regarding the execution of quality processes.
Help manage the critical document control system. Ensure all facility documents are revised, made effective, and archived in a controlled manner.
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.
Initiate and investigate deviations related to manufacturing and product release, identifying effective Corrective and Preventive Actions (CAPA) to improve overall processes.
Direct others executing validation work, review completed work, and ensure all tasks align with the established plan.
Track QA system progress through internal auditing and tracking/trending manufacturing errors to support Key Performance Indicators (KPIs).
Inspect incoming materials to ensure they meet all technical specifications for manufacturing use.
Act as a writer and resource for policies, standard operating procedures (SOPs), forms, worksheets, and job aids.
Serve as liaison for manufacturing projects and assist in training other QA/QC team members on quality systems.
Requirements and Preferences
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 Experience and Skills
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).
Wolfpack Perks and Benefits
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 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.
Recruitment Anticipated Hiring Range: $33.65 hourly
Job Open Date: 06/16/2026
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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  • Raleigh, North Carolina, United States

Compétences linguistiques

  • English
Avis aux utilisateurs

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