Quality Engineer

Responsibilities

• The Quality Assurance Engineer represents the Quality function in internal and external meetings related to new client projects, determining deliverables and timelines, and communicating upcoming activities with all of the Quality Organization (Quality Assurance, Quality Control and Validation). 
• Support technology transfer of product and processes from clients into August Bioservices manufacturing and laboratories from the Quality perspective.  Project may span R&D, Formulation Development, Clinical, and Commercial Manufacturing.
• Works cross functionally with various internal departments to effectively transfer and maintain processes in the facility. 
• Help proactively identify CMC critical path items, risks, and impediments to successful transfer, and drive the identification and development of solutions to help mitigate these risks. 
• Provide support on projects to streamline new product introduction, provide feedback in Change Review Board for change controls to introduce new products. 
• Develop and implement phase appropriate strategies for efficient transfers and identification of Quality deliverables.
• Works with Product Quality Assurance and Manufacturing to support generation of appropriate batch documentation.
• Communicates project status, upcoming deliverables and timeliness to the Quality Organization.
• This position will work in a cross-functional group with Manufacturing, Engineering, Supply Chain, and Commercial Operations to drive technical transfer of client products into August Bioservices for manufacture and laboratory testing. 
• This position will be client facing and the candidate should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.
• Provides support during internal audits and regulatory inspections. 
• Adhere to company policies and applicable regulatory agencies requirements (ICH, FDA etc.) to ensure compliance.
• Communicate clearly with cross-functional teams.

Requirements

• Bachelor’s or Master’s Degree and 5+ years of experience in Quality Assurance within a biotechnology, biologics, or pharmaceutical manufacturing facility.   
• Must have proven track record with CMC and technology transfer.
• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge preferred.
• Work occurs in a fast-paced environment. Individual must be able to efficiently prioritize own work and quickly communicate project information to the team.

Physical Requirements

• 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.
• Prolonged periods sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.