QC Chemist

Rockwell, NC

Responsibilities

• Perform the receipt and logging of incoming pharmaceutical ingredients
• Perform the sampling of incoming pharmaceutical ingredients for internal laboratory testing and shipment to external contract laboratories for testing
• Perform internal laboratory testing (e.g., organoleptic tests, identification (FTIR), pH, viscosity, specific gravity, chemical assays (HPLC), etc.) on incoming pharmaceutical ingredients, in-process samples, finished products and stability samples
• Calculate adjustments for in-process bulk product
• Prepare and review internal laboratory testing and external contract testing laboratory reports for raw materials, in-process samples, finished products and stability samples
• Prepare and review Certificates of Analysis
• Notify manager immediately of non-conforming data or unexpected occurrences
• Conducts laboratory investigations under the supervision of the laboratory supervisor
• Prepare and/or review test procedures, SOPs and protocols as assigned.
• Prepare and review IQ/OQ/PQ Protocols for production and laboratory equipment
• Perform IQ/OQ/PQ testing on production and laboratory equipment
• Complies with all regulatory/in-house requirements which may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP documentation

Requirements

• Combination of advanced degree (such as Bachelors in Chemistry or related science) and 3+ years of experience in high volume manufacturing preferred; extensive years of experience in lieu of advanced degree is acceptable
• Previous experience within a cGMP compliant facility, Quality Control and USP Standards preferred
• Ability to perform physical sampling/testing and instrumental chemical analysis in the chemical laboratory (e.g., chromatography, infra-red spectroscopy, titrations, etc.)
• Excellent analytical and problem-solving skills
• Excellent time management and organizational skills
• Ability to work effectively in a fast-paced, rapidly changing environment
• Excellent people skills, with demonstrated ability to communicate effectively across functional groups
• Proficiency with Microsoft (MS) Office