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- Elkhart, IN
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Quality Specialist - Investigation/CAPA/Change Control
KIK Custom Products • Elkhart, IN
Posted 13 days ago
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The Investigation/CAPA/CC Quality Specialist oversees and administers KIK’s quality programs involving Investigations, CAPA (Corrective Actions Preventative Actions), and CC (Change Control); coordination of compliance through initiation and closure of items related to the programs. The Investigation/CAPA/CC Specialist must be able to work professionally with internal staff and customers. This position reports to the site Quality Systems Manager.
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.
- Maintains CC log. Assigns numbers for new CC and communicates with owner. Provides site management with list of open CC on a regular basis. Tracks CC to closure. Ensures no CC goes beyond the assigned due date. Processes due date extensions, as needed.
- Conducts routine meeting for review of investigations, CAPA, CC and any other pertain quality topics or information by scheduling a conference room and inviting management and investigation/CAPA/CC owners. Records and maintains meeting minutes.
- Provides guidance/training to site personnel on the Investigation/CAPA 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.
- 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
- 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%
KIK is an Equal Opportunity / Affirmative Action Employer