Responsibilities:

• Ensure the document control system is maintained and managed via cataloguing, circulating, sending out training update notices and maintaining documents.
• Maintain secure control of all records for which the team is responsible, to include scanning into drive and filing.
• Maintain the training tracking system, training files and training binders.
• Maintain the calibration program for all facilities.
• Maintain the document control system, ensuring timely release of new and newly revised documents, sending out training update notices, and filing of documents.
• Collect and report metrics to drive the achievement of specific goals pertinent to the position.
• Participate as a resource in process/product validations.
• Assist with maintenance of the Device History files and other quality system documents.
• Participate in internal audits and external agency inspections.
• Assist with review of Nonconformance/Deviation, CAPA and Change Control systems to ensure timely documentation and closure.
• Assist others, as needed, with information or reviews to support investigations.
• Review batch records and other associated documentation to ensure compliance with SOPs, Work Instructions, and cGMPs.
• Assist with disposition of finished product in accordance with SOPs and Work Instructions.
• Assist with review of incoming inspection documentation.
• Supports internal and external supplier audits and inspections.
• Perform other Quality Systems/Quality Assurance duties as required to ensure compliance in the QMS.

Requirements:

• Working knowledge of current and applicable GMP regulations e.g.: 21 CFR Part 820/ ISO 13485.
• Working knowledge 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.
• Excellent verbal/written communication.
• With minimal direction, 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.
• Experience working in IVD industry a plus.
• Advanced MS Office skills to include Excel