QA/QC Project Lead - Permanent - Bonita Springs, Florida
We are seeking an experienced QA/QC Project Lead to support an early-stage radiopharmaceutical manufacturing operation. This position blends quality assurance and quality control responsibilities in a hands-on environment where system ownership and operational execution are essential prior to functional specialization.
As the organization grows, this role may expand to include building and leading additional quality resources.
This individual will collaborate closely with cross-functional teams including Engineering, R&D, Procurement, Facilities, and Project Management.
Primary Responsibilities:
The successful candidate will play a key role in advancing early-phase GMP activities, ensuring alignment between laboratory and production functions, and supporting equipment, starting materials, and intermediates used in clinical development.
Skills & Requirements:
- Bachelor's degree in a life sciences field or related discipline (or equivalent experience)
- 7+ years of experience in QA/QC or combined quality and radiopharmaceutical manufacturing within a cGMP environment
- Working knowledge of FDA/cGMP regulations (21 CFR 210/211) and relevant ICH guidelines
- Experience in a radiopharmaceutical production facility is preferred
- Strong understanding of quality systems and demonstrated success managing complex projects
- High attention to detail and ability to interpret regulatory requirements and standards
- Excellent written and verbal communication skills, including technical documentation and reporting
- Strong analytical and troubleshooting skills; experience in fast-paced technical environments is highly valued
- High integrity, collaborative mindset, and ability to foster teamwork
Working Environment
This role may involve work in cleanroom manufacturing areas, laboratory settings, and office environments. Physical and environmental conditions may include:
- Exposure to varying indoor and outdoor temperatures
- Extended periods of computer use, sitting, or standing
- Use of stairs and repetitive keyboard work
- Tasks requiring fine motor skills, bending, and grasping
- Noise levels ranging from quiet to moderate depending on the work area
- Visual requirements including near vision and color discrimination
Personal protective equipment (PPE) is required and may include respirators, gloves, safety glasses, and protective clothing. Compliance with cleanroom gowning standards is mandatory.
Radiation Safety
Employees may work in areas where radiation is present. Responsibilities may include:
- Adhering to established radiation safety procedures
- Participating in required monitoring and safety programs
- Reporting health conditions that could affect cleanroom or product integrity standards
The QA/QC Project Lead's responsibilities will be:
Quality Assurance
- Lead the development and implementation of early-phase quality programs
- Support end-to-end early production activities, including batch record review, approval, and material/product disposition
- Drive technology transfer and scale-up initiatives tied to production expansion
- Author and maintain GMP documentation and procedures
- Assist with implementation and improvement of quality systems (e.g., QMS, EDMS, LMS)
- Ensure quality initiatives appropriately balance operational safety requirements, including radiation safety
Quality Control
- Serve as a subject matter expert in key QC functions
- Provide on-site QC oversight of manufacturing operations
- Develop and maintain procedural controls for component inspection, product testing, and laboratory analysis
- Support in-house analytical methods and instrumentation
- Oversee QC activities related to batch release
- Contribute to stability studies and product validation testing
Additional responsibilities may be assigned to support evolving organizational needs.
If you are having difficulty in applying or if you have any questions, please contact Anthony Rabinkov at a.rabinkov @proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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