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Quality Specialist

Company: Voyant Beauty
Location: Elkhart
Posted on: June 13, 2022

Job Description:

General Summary: The NC/Investigation/CAPA/RCA Quality Specialist oversees and administers Voyant Beauty's quality programs involving Non-Conformances, Investigations, CAPA (Corrective Actions Preventative Actions), and RCA (Root Cause Analysis); coordination of compliance through initiation and closure of items related to the programs. The NC/Investigation/CAPA/RCA Specialist must be able to work professionally with internal staff and customers. This position reports to the Site Head of Quality.

Essential Job Functions

--- Conducts investigation meetings for new investigations.

--- Maintains investigation log. Assigns numbers for new investigations and communicates with investigation owner. Provides site management with list of open investigations on a regular basis. Tracks investigations to closure. Ensures no investigation goes beyond the assigned due date. Processes due date extensions, as needed.

--- Maintains CAPA log. Assigns numbers for new CAPA and communicates with owner. Provides site management with list of open CAPA on a regular basis. Tracks CAPA to closure. Ensures no CAPA goes beyond the assigned due date. Processes due date extensions, as needed.

--- Assists with NC's as they relate to the overall Quality system and investigations/CAPAs. Tracks and trends NC's, assigning investigations/CAPA's where needed. Provides site management with list of trending non-conformances on a regular basis. Tracks NC's to closure. Ensures all NC's are addressed and provides guidance for any corrective actions.

--- Acts as a Root Cause Analysis/FMEA leader to assist in determining true root cause and effective, long-term corrective actions.

--- Conducts routine meetings for review of investigations, CAPA, NC's and any other pertain quality topics or information by scheduling a conference room and inviting management and investigation/CAPA/NC owners. Records and maintains meeting minutes.

--- Provides guidance/training to site personnel on the NC/Investigation/CAPA/RCA process.

--- Serves as backup scribe and/or runner for customer and regulatory audits.

--- Serves as internal auditor in mock audits or internal audits to assist a lead internal auditor, as needed.

--- Serves as SME for quality programs during regulatory and customer inspections. Coordinates with Document Control to ensure documentation is provided to staging room.

Education Requirements

--- Bachelor degree (or higher) in area of discipline

--- Minimum 2 years' experience in cGMP regulated environment.

--- Experience in FDA regulated manufacturing environment required - Ideal experience in personal care, OTC or pharmaceuticals manufacturing

--- Experience in investigations, CAPA's and RCA's/FMEA's, PFMEA's ideal

--- Collaborative with an autonomous and self-sufficient work style. Comfort in multi-tasking and managing multiple projects at once are a must. Candidate must possess strong interpersonal, detail, and organizational skills.

--- Travel less than 10%

Keywords: Voyant Beauty, Elkhart , Quality Specialist, Other , Elkhart, Indiana

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