What are the responsibilities and job description for the Chemistry Supervisor position at Fagron Sterile Services US (FSS)?
About the Job
The Chemistry Supervisor is responsible for overseeing the operations of the chemistry laboratory. Duties include managing direct reports, acting as Subject Matter Expert (SME) and contributing to audit readiness. Perform routine testing and peer review as needed.
Key Responsibilities
- Management of lab staff including completion of performance feedback, reviews, disciplinary action and timecard administration
- Ensure testing is initiated and performed in a timely manner and adhering to quality standards
- Act as laboratory SME
- Draft protocols and coordinate with laboratory manager to conduct investigations and special studies as needed
- Draft and edit SOPs as needed
- Approve CoAs as needed
- Conduct and/or approve method validations as needed
- Review of paperwork for compliance
- Draft reports and communicate results
- Perform analytical chemistry work including but not limited to:
- HPLC/UPLC
- Infrared spectroscopy
- UV/Vis spectroscopy
- pH
- Titrations
- Karl Fisher (volumetric and coulometric titration)
- Loss on drying
- TOC
- Conductivity
- General lab duties as pertaining to safety and cleanliness
- Perform advanced chemical analysis and investigations for high risk or out of specification products, including Corrective and Preventative Actions and follow-ups
- Execute performance qualifications and validations
- Review Quality documentation for completeness and compliance, forward as required
- Participate in continuous improvement of the Quality department and site as a whole; record keeping, lab processes, site safety, etc.
- Other duties as assigned
Basic Qualifications
- Bachelor's degree or equivalent in chemistry or related scientific field, graduate degree is a plus
- Working knowledge of Current Good Manufacturing Practices and appropriate sections of CFR
- 210 and 211
- Six (6) years of experience in an analytical chemistry laboratory, combined laboratory and
- pharmaceutical quality experience will be considered (graduate degree may be considered as
- contribution to experience)
- Previous management experience preferred
- Knowledge of cGMP/GLP/GDP, USP, FDA regulatory requirements
- Excellent interpersonal communication and organizational skills
- Demonstrated leadership skills
- Qualified to work with controlled substances
- Experience Handling Biohazardous materials
- Ability to manage multiple direct reports and provide performance feedback
- Ability to establish priorities, work independently and proceed with objectives
- Ability to manage project work while managing daily duties and completing all on time
- Ability to adapt to new or updated processes
- Ability to troubleshoot problems with analytical equipment and perform or suggest appropriate actions
- Ability to work with team members and other departments to accomplish goals