UTS - Temporary Quality Assurance Associate at UNC Chapel Hill

About the role

Your daily responsibilities will include providing direction and setting clear expectations for ACT facility employees regarding the execution of quality processes, helping manage the critical document control system, assisting in the creation and issuance of batch records and required process forms, completing initial reviews of executed batch records, identifying necessary corrections, collaborating with teams to resolve issues related to deviations, initiating and investigating deviations, identifying effective Corrective and Preventive Actions (CAPA) to improve overall processes, directing others executing validation work, reviewing completed work, ensuring all tasks align with the established plan, tracking QA system progress through internal auditing, supporting Key Performance Indicators (KPIs) by analyzing manufacturing errors, inspecting incoming materials to ensure they meet all technical specifications for manufacturing use, acting as a writer and resource for policies, Standard Operating Procedures (SOPs), forms, worksheets, and job aids, serving as a liaison for manufacturing projects, and assisting in training other QA/QC team members on quality systems.

Responsibilities

• Provide direction and set clear expectations for ACT facility employees regarding the execution of quality processes.
• Help manage the critical document control system.
• Aid 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.
• Identify 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 track/trend 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, SOPs, forms, worksheets, and job aids.
• Serve as a liaison for manufacturing projects and assist in training other QA/QC team members on quality systems.

Requirements

• A Bachelor of Science degree in Biology, Chemistry, Bioengineering, or a related scientific discipline; equivalent industry experience will be considered.
• 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).
• Demonstrated experience with initial batch record review, document control processes, and standard technical writing (including standard operating procedures and worksheets).
• Proven experience initiating and documenting deviations or non-conformances within a production setting.
• Ability to complete necessary Environmental Health and Safety (EHS) modules and maintain strictly mandated annual competencies.
• Proven experience in a Quality Assurance or Quality Control role within a regulated manufacturing environment (experience in cellular therapy is highly valued).
• Proficient with Electronic Quality Management Systems (eQMS); experience with MasterControl is highly beneficial.
• Strong technical writing skills, exceptional attention to detail, and the ability to investigate root causes effectively.
• Ability to maintain annual competencies in required quality functions and remain current with Environment, Health, and Safety (EHS) Learning Management System (LMS) modules.
• Willingness to participate in a minimum of five hours of continuing education annually in cellular therapy or quality topics.

Qualifications

• Prior experience working specifically within cellular therapy, biologics, or blood banking facilities.
• Direct, hands-on experience utilizing MasterControl or a similar electronic Quality Management System (eQMS).
• Experience overseeing or reviewing validation protocols and executed work packages against an established project plan.
• Experience leading root-cause analysis investigations and authoring Corrective and Preventive Action (CAPA) plans.
• Familiarity tracking manufacturing errors and analyzing metrics to support corporate Key Performance Indicators (KPIs).

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.
• Technical Skills: Proficient with Electronic Quality Management Systems (eQMS).
• Experience with MasterControl is highly beneficial.
• 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).

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.

Pay

$33.65/hourly

Schedule

Monday–Friday, 8:00 AM–5:00 PM