Manager Quality Floor Support
Manager Quality Floor Support
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Position Summary:
The Manager Quality Floor Support (QFS) is primarily responsible for ensuring that their shift provides onthefloor 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 tomaintain a cGMP environment as well as representation at shift changeover 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 InProcess Event (IPE) documentation authors rework instructions reviews AQL packets and autoclave alarm response forms.
- Creates nonconformance and nonconformity records in TrackWise. Performs and authors nonconformance investigations and CAPAs using Root Cause Analysis tools (i.e. 5 WHYS 5ME Is/Is Not)
- Trends and reports IPE events. Takes an active role in crossdepartmental meetings devoted to the review discussion and trending of process and performance data.
- Monitors nonconformance 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 oncall weekend quality support for bioMrieux 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 problemsolving 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.
#BmxDUR
Required Experience:
Manager
Employment Type
Full Time
