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Chemistry Supervisor
2 months ago
Over de functie
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.
Role/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
Wat wij vragen
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
Over het bedrijf
Established in 1990, we have grown into a trusted global company becoming a leading player in personalized medical solutions. Thanks to our talented team of over 2,000 professionals located in 34 countries, we proudly satisfy the needs of over 200,000 customers around the world. From leading-edge compounding to natural products, from software to equipment, and pioneering genomics, we aim to deliver, on a global scale, ready-to-use and ready-to-administer innovative and high-quality personalized solutions that enhance medical compliance and significantly improve healthcare. Our people are driven by passion, a solid scientific core, and a dedication to innovate. We collaborate with our partners to continuously improve and discover new solutions, to bring quality to customers and positively impact people’s lives.
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