We are seeking a Senior QA Specialist for a hand-on role at our manufacturing facility. This is a hands-on role for a problem-solver who thrives on the manufacturing floor. You will partner directly with Manufacturing and Engineering teams to ensure our gene therapies are produced to the highest standards of safety and efficacy, focusing on real-time quality support, batch record review, and deviation management.
location: Morrisville, North Carolina
job type: Temporary
salary: $60 - 68 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Act as the primary QA point-of-contact for manufacturing operations. Perform line clearances, real-time batch record review, and walk-throughs to ensure cGMP compliance.
- Lead investigations for manufacturing deviations. Utilize Root Cause Analysis (RCA) tools (e.g., 5-Whys, Fishbone) to identify true root causes and implement effective Corrective/Preventive Actions (CAPA) that prevent recurrence.
- Execute comprehensive technical reviews of executed batch records, QC data, and logbooks to support timely lot disposition.
- Identify gaps in procedures and partner with the manufacturing team to revise SOPs, making them more robust and user-friendly.
qualifications:
Required:
- B.S. in Biology, Chemistry, Engineering, or related field.
- 5+ years of QA experience in the pharmaceutical/biotech industry.
- Strong understanding of FDA 21 CFR Part 210/211 and sterile manufacturing processes.
- Gene Therapy/AAV experience
skills: Data Analysis, Assay Development, Assay Method, Assay Verification, Data Management Plan, Deviation Management, CRO Oversight, Cross Functional Collaboration, Data Security and Privacy, Corrective and Preventive Actions (CAPA), Change Control Management, Quality Assurance (QA), Aseptic Processing, Biologics Manufacturing, Batch Record, Data Interpretation and Presentation, Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
