Job Description
Job DescriptionJob Title: Quality Assurance SpecialistJob Description
As a Quality Assurance Specialist, you will be an integral part of a cGMP Manufacturing site, providing essential support to the CMC clinical manufacturing program. Your primary responsibility will be to ensure real-time quality oversight on the manufacturing floor, focusing on adherence to aseptic techniques and GMP principles during processing. This role requires strong decision-making skills and the ability to think independently. You will collaborate closely with the Manufacturing, Quality Control, Validation, Supply Chain, and Facility teams.
Responsibilities
- Provide quality on-the-floor support of manufacturing processes, reviewing batch record documentation, and offering real-time support for manufacturing issues and changeovers.
- Participate in quality oversight of manufacturing through real-time observations of activities, offering guidance on GMP principles and aseptic techniques during routine operations.
- Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation.
- Establish and follow written procedures for the accurate documentation of equipment operation, process instructions, and process data.
- Perform routine walkthroughs of manufacturing suites, collaborating with manufacturing on suite maintenance, implementing quality best practices, and troubleshooting problems.
- Review and approve Environmental Monitoring results associated with GMP operations.
- Review and approve facility alarms, work order requests, inventory requests, batch record requests, and return-to-service documentation.
- Support, review, and approve Deviations and Change Controls.
- Partner with manufacturing and support teams to initiate and triage new deviation events, and review minor and major manufacturing deviations.
- Oversee execution of remediation/CAPA activities required to continue production or progress a process to the next milestone.
- Manage multiple assignments and projects in a fast-paced environment.
- Collaborate and lead effectively in a dynamic, cross-functional matrix environment.
- Author and review SOPs and policies to ensure compliance and adherence to regulations and cGMP operations.
Essential Skills
- GMP inspection
- Batch record review
- Document control
- Audit, investigation, and analysis in Quality Assurance
- Experience in cell or gene therapy
- Deviation management and CAPA resolution
Additional Skills & Qualifications
- Bachelor's degree in applied science
- 2+ years of relevant experience in Quality Assurance within cGMP aseptic manufacturing operations
- Preferred experience in cell or gene therapy
- On-the-floor manufacturing quality assurance experience
Work Environment
This role involves working in both lab and office settings. The lab is a cleanroom environment with level 10k and 100k specifications. The position requires sterile gowning and maintaining certification for sterile gowning.
Job Type & Location
This is a Permanent position based out of WINSTON SALEM, NC.
Pay and Benefits
The pay range for this position is $70000.00 - $80000.00/yr.
Will provide as requested.
Workplace Type
This is a fully onsite position in WINSTON SALEM,NC.
Application Deadline
This position is anticipated to close on Jan 31, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.