Position Summary:
The Quality Floor Support (QFS) Specialist 1 is responsible for providing quality oversight and guidance on the production floor. In this capacity, they identify and resolve exceptions in production areas and review data and records for GMP compliance. The QFS Specialist 1 routinely performs and documents walkthrough audits of bioMérieux production, warehouse and support areas. They support quality continuous improvement and investigation activities, including but not limited to customer complaints, nonconformance investigations and CAPAs.
The normal hours for this role are anticipated to be Monday - Friday from 3:00pm - 11:30pm. This role also works on a rotation, working one Saturday every three weeks.
Primary Responsibilities:
- Documents and communicates quality observations made during production facility walk-through audits.
- Initiates In-Process Events (IPEs) and collects all associated documentation; reviews and approves AQL packets.
- Opens nonconformance initiation records in TrackWise and attaches all relevant supporting documentation.
- Reviews manufacturing logbooks and documentation on-the-floor for BacT/ALERT products to make sure they are complete, filled out correctly and entries comply with BMX controlled documentation procedures.
- Provides training to manufacturing personnel on open waivers and rework as needed to support product release.
- Ensures MFG areas post construction/cleaning are back in a validated state and authorizes the release of production areas.
- Completes continuous improvement projects, as assigned.
- Revises SOPs, job aids, forms and attachments as part of change control process, as assigned.
- Supports internal/external audits, as needed.
- Performs final product AQL Inspections and assists with training new AQL inspectors, as needed.
- Provides on-call weekend quality support for BioMérieux production activities.
Education, Skills, & Experience:
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Associate’s degree with 2 years of experience in a manufacturing environment, GMP preferred OR Bachelor’s degree with 0 years of experience also accepted
- Degree in Engineering, Biotechnology, Microbiology, or Biology, highly preferred
- Candidates graduating in December 2024 also considered
- Experience working in a regulated, GMP environment and/or individuals with experience working in a GLP or college/university laboratory environment with knowledge of Good Documentation Practices is preferred.
- Exhibits both analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to apply a quality mindset when completing tasks.
- Demonstrates the ability to become familiar with relevant domestic and international regulations and industry standards (e.g. ISO, FDA, IVDR, QSR).
- Strong interpersonal skills and ability to work with all levels of an organization.
- PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
