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Akorn, Inc Quality Control Supervisor I in Somerset, New Jersey

SUMMARY: 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 GMP requirements and testing timelines are met. ESSENTIAL FUNCTIONS: \* 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 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 method and instrument challenges. \* Ability to successfully work on cross-functional basis with other site supervisors. \* Maintains knowledge of current trends in Quality Control testing procedures by remaining knowledgeable of updates to current USP and vendor testing methodologies. \* Write, review, and revise SOP's as required. \* Familiarity with writing and reviewing product transfer and USP/vendors' method verification protocols and reports. \* Ability to write comprehensive out-of-specification (OOS) investigation and out-of-trend (OOT) reports. \* Ensure Laboratory mistakes are kept to a minimum and repeats are rare \* Maintain lab equipment in good working order and ensure calibration plan is followed. \* Assure stability testing plan is maintained and provide data for annual reports for commercial products. \* Ensure laboratory is prepared for internal and external audits \* Assure proper reagents, solvents, columns, reference standards and other lab supplies are maintained in the lab to support testing. \* 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 QUALIFICATIONS: 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: \* Excellent interpersonal, oral, and written communication skills. \* Requires exceptional attention to detail with the ability to focus on current assignments.. \* Requires initiative and self-motivation with moderate supervision in a detail-oriented manner. \* Requires the ability to work on multiple projects concurrently. \* Must possess the ability to work in an independent manner, as well as a group environment. \* Responsible for maintaining confidentiality of work assignments \* Works compliantly in a fast paced, moderately stressful environment. Adherence to compliance and 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 \* Advanced trouble-shooting skills with the ability to recognize methodology deficiencies \* Must be able to perform equipment troubleshooting and communicate with equipment manufacturer. \* 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 5 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. PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and mental requirements in To view the full job description, click here

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