Quality Assurance Manager

Responsibilities include quality systems oversight of our outsourcing facility in our Ledgewood, NJ location. This position reports to the VP Quality. The Quality Assurance Manager will meet the company goals for product quality and production efficiency. This position will ensure that the operations are following the cGMP standards promulgated under Sections 503B of the US Food, Drug & Cosmetic Act. The Quality Assurance Manager will provide guidance for improving production processes for a greater reliability and simplicity. The successful candidate must have the demonstrated ability to build and maintain relationships, trust, and respect with clients, vendors and peers. Position Responsibilities Ensure compliance with US Food, Drug & Cosmetic Act, Section 503B, and all of its cGMP elements related to facilities, utilities, warehousing, production, testing, documentation, training, reports and records  Review and approve a variety of complex 503B quality systems documentation in multiple technicals areas, including SOPs, batch records, protocals, forms, checklists, etc. Provide ongoing support for the manufacturing of aseptic drug products Maintain quality systems activities such as metrics, documentation management, risk assessment, etc. Perform Root Cause Analysis (RCA) and implement effective Correct Action and Preventative Action (CAPA) to address operational and laboratory issues and investigations Assist with supplier qualifications and internal and external audits Must be able to manage a heavy workload and aggressive timelines, prioritize and work under pressure Participate in cross-site communication and information sharing to ensure communication and implementation of industry best practices Support implementation of projects within budgets and projected timelines Perform duties in accordance with established company procedures and policies; perform other duties as assigned Requirements Bachelor's degree in Science, Microbiology, or Engineering or related field or equivalent work experiencerequired 5-7 years of progressive experience within cGMP quality operations and aseptic/parenteral manufacturing or equivalent technical experience Recent experience with validation of aseptic drug product bulk manufacturing process preferred A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices Familiarity with manufacturing process and operations, automation, equipment/facilities validation Ability to complete tasks with little direction or need for supervisory follow-up Strong written, verbal and presentation communication skills Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other must be able to learn additional software as required) Ability to think creatively in confronting new issues and pursuing novel approaches to old problems Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards Ability to travel up to 10% of the time. Must be able to travel independently as an Imprimis Pharmaceuticals, Inc. representative   Work Environment/Physical Demands The employee may frequently be required to sit and talk or hear The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch The employee must occasionally lift and/or move up to 25 pounds May work with hazardous materials and chemicals Cleanroom environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no makeup or jewelry can be worn when working in the clean room environment Specific vision abilities by this job include close vision, depth perception and ability to adjust focus  
Salary Range: NA
Minimum Qualification
5 - 7 years

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