At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.
We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.
Come be a part of our team and our mission as an Audit Coordinator!
Essential Job Duties and Responsibilities
- Perform responsibilities in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System.
- Assist in the following items with respect to external, internal, and supplier, audits:
- Work with stakeholders and SMEs to schedule external, internal, and supplier, audits.
- Record audit activities and action items.
- Track and follow-up on the completion of action items.
- Coordinate responses to external audit requests as necessary.
- Schedules post-audit Lessons Learned meeting.
- Use of project scheduling and planning tools to monitor progress and adherence to planned completion dates.
- Track the progress of audits being performed by internal and supplier auditors.
- Assist in the management and input data for audit related reports, which may include creation of graphs, charts, and the annotation of data.
- Assist in reporting relevant audit information to Quality management, which includes information about audit status, and issues potentially impacting the completion of audits to agreed upon dates.
- Performs other duties as assigned.
Minimal domestic travel may be required for training purposes
Training and Education
- High School diploma or equivalent required.
- Associates Degree, or higher, in life sciences or engineering discipline preferred.
- At least one year work experience in a regulated industry (examples of industry: laboratory, medical device manufacturing that has a formal quality management system (e.g. ISO 13485, ISO 9001 or follows Good Manufacturing Practices (GMP))
- Experience in/or firm understanding of Medical Device Regulations is preferred but not required; e.g. 21 CFR 820, ISO 13485, ISO 9001.
- Training/experience with Technical writing is preferred but not required.
Knowledge, Skills and Abilities
- Proficient in MS Office applications such as Word, Excel, PowerPoint, and Outlook.
- Experience with MS Visio or Lucidchart is preferred but not required.
- Good communication skills, both oral and written.
- Good attention to detail.
- Good organizational skills, demonstrating effective management of paperwork and task schedule.
- Ability to effectively follow written and verbal instructions.
- Ability to demonstrate effective critical listing and thinking.
- This position requires a high degree of self-sufficiency, professional verbal and written communication and high attention to detail.
Must be able to sit/stand for >75% of time and look at computer monitors for extended amounts of time with or without accommodations.