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Quality Assurance Manager

Title: NJOF Quality Assurance Manager Status: Exempt
Reports to: VP of Quality Supervises: n/a
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
Bachelors degree in Science, Microbiology, or Engineering or related field or equivalent work experience required
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
About Imprimis Pharmaceuticals
ImprimisRx is one of the nations leading ophthalmology compounding businesses ImprimisRx is headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRxs 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP), the highest federal quality standards for drug manufacturers in the country. Its 503A pharmacy produces customizable, patient-specific formulations pursuant to a physician prescription for several chronic care needs. There have been over one million eyes served by the formulations produced at these facilities.
Diversity creates a healthier atmosphere: All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Imprimis Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
AAP/EEO Statement
Imprimis believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a can-do attitude and fostering a collaborative and mutually supportive environment.
Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to age, ancestry, race, color, religion, sex, national origin, protected veteran status, disability status, marital status, medical condition, genetic information, national origin, gender (including gender identity and expression), or sexual orientation.
Imprimis Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time, with or without notice.

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