Responsibilities:

• Review batch records including but not limited to manufacturing batch records, packaging records, QA data, investigations, protocols, and other associated documentation to assure they are compliant with SOPs, Work Instructions, and cGMPs.
• Disposition finished product in accordance with SOPs and Work Instructions.
• Assist in document management via cataloguing, circulating and maintaining documents.
• Participate in the Nonconformance/Deviation, CAPA and Change Control systems with timely documentation and closure.
• Assist in maintaining the training tracking system and send out training update notices.
• File and maintain training binders.
• Collect and report metrics and drive the achievement of goals pertinent to the position.
• Participate as a resource in validations applicable to processes and product.
• Assist with maintenance of the Device History files and other quality system documents.
• Assist others, as needed, with information or reviews to support investigations.
• Maintain secure control of all records for which the team is responsible.
• Assist with internal audits and external agency inspections.
• Perform other Quality Systems/Quality Assurance duties as required.

Requirements:

• Must be knowledgeable of current and applicable GMP regulations
• Must have understanding of Nonconformance/Deviation, CAPA and Change Control programs with experience in writing and reviewing of documentation for these processes.
• Detail-oriented and excellent problem-solving skills.
• Ability to positively interact with internal associates to quickly and effectively resolve documentation related issues.
• Must have the ability to prioritize and manage multiple tasks simultaneously in a fast-paced environment.
• Advanced computer skills (Excel, Power Point, MS Word, etc.).
• Requires a Bachelor’s degree in technical field and 1-3 years of experience; or equivalent combination of education and experience.
• Experience with laboratory or manufacturing quality assurance activities.