A premier, FDA-registered 503B outsourcing facility is seeking a Senior Quality Assurance Specialist / Associate Manager to join their team on-site in Lutz, FL (Tampa area). This role offers a unique opportunity to work closely with leadership, helping establish critical documentation systems in the near term while supporting commercial sterile manufacturing and inspection readiness for the long haul.
location: Lutz, Florida
job type: Permanent
salary: $80,000 - 110,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Review and approve batch records, deviations, investigations, CAPAs, and change controls.
- Provide robust QA oversight for sterile compounding, aseptic processing, and cleanroom activities.
- Partner with the Head of QA to establish and build out essential quality paperwork and site documentation.
- Ensure the facility maintains continuous compliance with 21 CFR Parts 210/211 and USP guidelines.
- Support regulatory inspection readiness for FDA, state board, and customer audits.
qualifications:
Required:
- Bachelor's degree in a scientific discipline (Chemistry, Microbiology, Biology, etc.) or Engineering.
- 5+ years of pharmaceutical QA experience (Specialist level) or 5-7 years with leadership experience (Associate Manager level).
- Direct, hands-on experience with sterile product manufacturing.
- Comfortability working within paper-based quality documentation systems.
- 503B outsourcing facility experience.
- Experience with environmental monitoring, media fills, and Certificates of Analysis (COA).
skills: Corrective and Preventive Actions (CAPA), Deviation Investigation, Quality Assurance (QA), Sterile Manufacturing, Batch Record, 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.
