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

Fagron

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Chemistry Supervisor