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  • Elkhart, IN

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Quality Specialist - Investigation/CAPA/Change Control

KIK Custom Products • Elkhart, IN

Posted 1 month ago

Job Snapshot

Full-Time
Experience - 2 years
Degree - 4 Year Degree
Manufacturing
QA - Quality Control, Research

Job Description

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.



Qualifications

  • 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%

www.KIKCORP.com

KIK is an Equal Opportunity / Affirmative Action Employer

Job ID: 2019-5801
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