SUMMARY: Schedules testing of raw materials, in-process materials, finished products and stability samples. Manage Quality Control team and compliance activities to achieve key site and corporate
The Supervisor, Quality Control will supervise the chemists and manage all aspects of quality team. Strategically manages the day to day lab operation to assure testing timelines are met.
objectives. Develops testing schedule for raw materials based on the production requirements, finished
products for marketing needs and stability samples to provide annual reports. Identifies areas in need of method modification and staff training. Acts as advisor to team members to meet schedules and resolve instrument problems. Ability to successfully work on cross-functional basis with other site supervisors. Maintains knowledge of current trends in Quality Control testing procedures by updating to
current USP and vendors testing methodologies. Write and revise SOPs as required. Familiarity with writing product transfer and USP/vendors method verification protocols and
reports. Ability to write effective out-of-specification (OOS) investigation and out-of-trend (OOT)
reports. Maintain lab equipment in good working order and calibration plan is followed. Assure stability testing plan is maintained and provide data for annual reports for commercial
products. Prepare laboratory for customer and FDA audits Assure proper reagents, solvents and other lab supply is maintained in the lab. Obtain quotations for lab equipment and contract testing. Work on the bench to perform sample analysis as required. Other duties as assigned or required.
QUALIFICATIONS: Excellent interpersonal, oral, and written communication skills. Requires exceptional attention to detail with the ability to focus on current assignments. While Laboratory mistakes are unavoidable they must be kept to a minimum due to their ramifications. Requires initiative and self-motivation with moderate supervision in a detail-oriented manner. Requires the ability to work on multiple projects in a concurrent manner. Must possess the ability to work in an independent manner, as well as a group environment. Responsible for maintaining confidentiality of work assignments Works in a fast paced, moderately stressful environment. Adherence to project deadlines is critical Proficient with computer programs desirable; or an aptitude to learn computer programs as needed. Proficient with the operation of instrumentation such as HPLC, UV, GC, KF, AA and FTIR Resourceful and well organized. Advanced trouble-shooting skills with the ability to recognize methodology deficiencies Must be able to perform equipment troubleshooting and communicate with equipment manufacturer. Requires comprehensive knowledge of raw materials/products chemical analysis and operation of laboratory instruments. Familiarity with GLP/GMP guidelines. Experience with USP/EP monographs. Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines. EDUCATION AND EXPERIENCE: BA or BS in chemistry Minimum 10 years of lab experience performing chemistry related duties and Minimum 3 years of supervisory experience in the pharmaceutical industry. Thorough knowledge of High Pressure Liquid Chromatography (HPLC), Gas Chromatograph (GC), Infra-Red (IR) Spectrophotometer, Ultra Violet/Visible (UV/VIS) Spectrophotometer, Particle Size Analysis, KF Titration and wet chemistry skills are required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES: