KIK Products Quality Operations Manager in Elkhart, Indiana
Our Elkhart, Indiana plant employs approximately 1000 associates and collectively contain 10 aerosol lines, 7 liquid lines, 3 tube lines, and 2 packaging lines. KIK Elkhart procures, blends, fills and packages a wide variety aerosol and liquid personal care, pharmaceutical, and OTC consumer packaged goods. There are 2 Warehouses at KIK Elkhart and one offsite.
The Quality Operations Manager manages and directs all quality operations activities to ensure adherence to all customer and regulatory requirements and finished good product specifications which includes all aspects of manufacturing and packaging.
Ensure manufacturing and packaging operations adhere to all regulatory, GMP and customer requirements for finished goods quality.
Responsible for managing all Quality Operations functions for Elkhart – West plant.
Support improvement of component, on-line and finished product inspection methods to ensure continuous quality improvement.
Manage Deviation, Investigation, and Corrective and Preventative (CAPA) reporting and response processes.
Assist with all customer and regulatory audits.
Provide technical assistance to other departments, suppliers and customers as needed.
Interact with customers as required to support new product startups and development.
Develop procedures, conduct training to comply with GMP regulations
Coordinate special projects as requested.
Leads and manages quality engineers assigned to West plant.
Minimum Education Requirements
- Bachelor Degree (or higher) in area of discipline.
Minimum Job Experience
Five (5) years in quality operations in manufacturing operations. While pharmaceutical industry experience is highly preferred, we may consider prior experience in personal care products / OTC.
Knowledge and work experience with FDA regulations 21 CFR part 210/211
Experience in contract manufacturing is preferred.
Must have strong leadership skills with successful track record of mentoring and developing staff members
Progressive record of growth in manufacturing quality.
Prior experience working with customers developing and maintaining relationships
Problem solving and root cause analyses
Relocation Assistance will be provided for ideal candidates outside of the area
KIK is an Equal Opportunity / Affirmative Action Employer
External Company Name: KIK Custom Products Inc.
External Company URL: www.kikcorp.com
Street: Elkhart Plant - Main