Position Summary:

The Manager Quality Floor Support (QFS) is primarily responsible for ensuring that their shift provides on-the-floor quality guidance for manufacturing processes, product documentation review, product inspection, product segregation and corrective actions. This is accomplished through the performance and documentation of routine quality walkthroughs in manufacturing areas including the warehouse and support areas to maintain a cGMP environment as well as representation at shift change-over and across department meetings.

The Manager Quality Floor Support (QFS) enables their direct reports to support quality activities, including but not limited to customer complaints, nonconformance investigations, change controls and CAPAs. They serve as quality representatives in the assessment of process issues and ensure QFS support for continuous improvement initiatives affecting manufacturing, inspection and quality system processes.

Responsibilities:

• Coordinates the activities of QFS personnel to provide solutions and corrective actions for quality observations in manufacturing areas.
• Directs quality walkthroughs of manufacturing areas and generates monthly QFS walkthrough and effectiveness check reports.
• Initiates, reviews and approves In-Process Event (IPE) documentation, authors rework instructions, reviews AQL packets and autoclave alarm response forms.
• Creates non-conformance and non-conformity records in TrackWise. Performs and authors nonconformance investigations and CAPAs using Root Cause Analysis tools (i.e. 5 WHYS, 5M+E, Is/Is Not)
• Trends and reports IPE events. Takes an active role in cross-departmental meetings devoted to the review, discussion and trending of process and performance data.
• Monitors non-conformance investigations and change controls assigned to their team for on time closure and effectiveness.
• Authors and reviews GMP documents including procedure revisions and specified reports, to support continuous improvement
• 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.
• Implements and completes continuous improvement projects.
• Initiates change controls and completes the revision of SOPs, job aids, forms and attachments as part of change control process.
• Ensures GMP data, logbooks and records are reviewed for compliance.
• Facilitates QFS support during internal/external audits, as needed.
• Performs final product AQL inspections and assists with training new AQL inspectors, as needed.
• Coordinates on-call weekend quality support for bioMérieux production activities.

Studies and Experience:

• High school diploma/GED with a minimum of 7 years of progressively responsible experience working in a regulated environment required.
  • Associates degree with a minimum of 4 years of progressively responsible experience or a BS degree with 2 years of progressively responsible experience working in a regulated, GMP environment preferred.
  • BA/BS degree in a field related to science, technology, engineering or mathematics is preferred.
• Minimum of three (3) years of experience involving team leadership and collaboration with multiple departments/function required.
• Good Documentation Practices (GDP) experience is preferred.
• CQE or CQA certification through ASQ an asset.

Skills and Qualifications:

• Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA, IVDR QSR).
• Must have strong verbal communication skills.
• Demonstrates the ability to work well in a complex, diverse environment and can function independent of direct supervision.
• Exhibits strong analytical, technical writing and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates competence in the selection and use of root cause analysis tools and techniques.
• PC skills, including proficiency in: Microsoft Excel, PowerPoint, Outlook and Word.
• Prior knowledge of TrackWise, SAP and/or SPC an asset.

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Job ID: 39362

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh