Quality Assurance Coordinator

The Quality Assurance Coordinator works closely within the Quality team to help to ensure the Autumn Harp Quality Compliance programs are up-to-date, accurate, and appropriately documented. This includes data entry, tracking and assisting with calibrations, pest control, and water sampling, and ensuring quality critical documentation is properly completed, stored, and tracked. The QA Coordinator I helps to represents the Quality Department in the manufacturing environment.

Job Responsibilities:

• Enters data, including for pest control, water sampling, customer complaints, and quality system elements such as deviations, investigations, and CAPAs. Tracks requirements, progress, and closures.
• Responds to routine customer complaints; gathers and trends data and tracks closures.
• Assist with training on Quality and documentation topics
• Administers calibration database and tracks calibration due dates. With support, conducts some internal instrument calibrations and works with external calibration vendors to ensure calibrations are conducted in a timely manner and all required paperwork is completed accurately and on-file.
• Supports internal pest control program and works with external vendor(s) to ensure program is maintained, documented as required, and updated as necessary.
• Ensures documentation is current, controlled and filed in accordance with the document control procedure.
• Maintains the Quality Systems Tracker database, tracks due dates, and works with relevant stakeholders to ensure there is follow-up and extensions requested as needed.
• Supports the Holds and Rejections Processes. Works with others in the department to ensure proper tracking, tagging, and follow-up.
• Supports the temperature and humidity monitoring programs, tracks logged data.
• Maintains accurate files and records, in compliance with customer, GMP and FDA regulations applicable to operations. Files all reports as necessary in a timely manner to remain in compliance.
• Helps to create an atmosphere that supports respect, honesty and open communication among all employees; encourages employees to celebrate accomplishments and have fun

Skills and Experience required:

• College preferred or related level of experience
• 1-3 years of quality-related experience within an ISO or FDA environment
• Proficiency in Microsoft Office, Excel, and database management
• Attention to detail and follow-up
• Ability to communicate well – both externally and internally
• Ability to work independently as well as being a productive and positive team player
• Ability to multi-task
• Excellent listening skills
• Comfortability asking questions and raising potential issues.