Quality Assurance Manager
Morristown, NJ 07852
We are looking for a Quality Assurance Manager with sterile drug manufacturing experience to join our team. The Quality Assurance Manager at our facility leads people, process and systems that deliver high quality sterile pharmaceutical products to our customers. Our 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.
- 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
- 3-5 years of progressive experience within cGMP quality operations and FDA regulationsor a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical 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 a representative
- Work flexible hours as the business demands, including overnight, weekends, and holidays.