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QA Manager/Sr. - Pharmaceutical Manufacturing

Company: ImprimisRx
Location: Ledgewood
Posted on: January 15, 2022

Job Description:

At ImprimisRx we are working hard to help our customers navigate the realities of the healthcare market by providing innovative medications that address both clinical and economic needs. To get there, we need exceptionally talented, bright, and driven people. If you would like to help us build a quality culture organization trusted by healthcare professionals from across the US, this is your chance to join us. We are looking for a dynamic, organized self-starter to lead our Quality Assurance initiatives for our New Jersey facilities. Responsibilities include quality systems oversight of our compounding pharmacy and outsourcing facility in our Ledgewood, NJ location. This position reports to the Director of Quality.

Job Summary

The successful individual will lead people, process and systems that deliver high quality sterile pharmaceutical products to our customers. Our ImprimisRx FDA Registered Outsourcing Facility is a complex operation which requires a leader who will meet the company goals for product quality and production efficiency. This position will ensure that the operations are in compliance with the cGMP standards promulgated under Sections 503A and 503B of the US Food, Drug & Cosmetic Act.

Position Responsibilities
Ensure compliance with US Food, Drug & Cosmetic Act, Section 503A and 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 503A and 503B quality systems documentation in multiple technical areas, including SOPs, batch records, protocols, 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.
Prepare quality related regulatory documents to support validation and commercial production
Perform Root Cause Analysis (RCA) and implement effective Correct Action and Preventative Action (CAPA) to address operational and laboratory issues and investigations
Facilitate pharmaceutical formulation testing by contract labs
Assist with supplier qualifications and internal and external audits
Assist in the development and approval of analytical and microbiology methods
Maintain database for environmental results of clean room environment and summarize data for annual environmental report
Must be able to manage 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
Assist in any recalls if necessary, including managing the recall process and archiving all recall data
Support implementation of projects within budgets and projected timelines
Perform duties in accordance with established company procedures and policies; perform other duties as assigned

Bachelor's degree in Science, Microbiology, or Engineering or related field or equivalent work experience required
5-7 years of progressive experience within cGMP quality manufacturing operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience
Previous management and supervisory experience.
Recent experience with validation of aseptic drug product bulk manufacturing process preferred
Experience in environmental monitoring of clean rooms, aseptic media fill evaluation, bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products according to USP 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 flexible hours as the business demands, including overnight, weekends, and holidays.

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

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 race, color, religion, sex, national origin, protected veteran status, or disability status.

Imprimis 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.

Keywords: ImprimisRx, Newark , QA Manager/Sr. - Pharmaceutical Manufacturing, Executive , Ledgewood, New Jersey

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