Manager - Quality Assurance & Compliance-NL Quality Control

at  Kdcone Northern Labs

KDC is a network of best-in-class custom formulators and manufacturers of color cosmetics, skincare, haircare, bath & body, fragrance, deodorant, home, health, industrial, and auto care products. KDC delivers high-touch innovation, operational excellence, and speed to market to well-known and emerging beauty, personal, and specialty companies from coast to coast. KDC has its head office in Longueuil, Québec. In addition, KDC has 10 operating facilities located throughout North America. Altogether, the company employs nearly 4,800 talented and dedicated employees in North America.
Job Title: Quality Assurance & Compliance Manager Reports To: VPGM
Job category: Individual contributor Management
Division: Home Care Department: Production Location: Manitowoc, WI
Description / Scope / Mission
Lead the plant Quality Control Unit and work with Production, Quality Control and Operations to ensure all products manufactured at Northern Labs meet established specifications in both product making and filling areas. This is to be accomplished through process and quality compliance and audits to ISO 9001, FDA-cGMP and BRCGS standards and any other applicable regulatory requirements. The purpose is to maintain regulatory compliance through validation, corrective action and other process improvement activities.
Key Responsibilities/ Accountabilities
1. Ensure that quality policies are consistently implemented and customer quality expectations are met.
2. Responsible for all product safety.
3. Promote the superior quality of the products, leading the Quality Control activities and defining the proper methods, measuring instruments and acceptance criteria.
4. Ensure that all required regulatory filings and forms are completed and filed on a timely basis and that the company maintains regulatory compliance with ISO9001, FDA cGMP’s, BRCGS standards, etc.
5. Interpret and implement regulatory activities for maintaining compliance with FDA cGMP’s.
6. Prepare Northern Labs’ for audits and lead ISO 9001, BRCGS and customer and regulatory audits and the closure associated with finding the route cause.
7. Have the authority to release or reject raw materials, components and finished goods and to stop the production, if required.
8. Coaching the quality team.
9. Facilitating the communication of, and developing methods to adhere to.
10. Conduct classroom training for cGMP and other quality system elements.
11. Coordinate the risk management processes, including the product risk assessment
12. Create and perform all validation activities as needed to support existing/new customers or internal process improvements.
13. Communicate with customers and suppliers (as necessary) about quality topics regarding for example: validation activities, quality issues, obtaining approvals on final protocols, etc.
14. Process and manage CPA’s (corrective/preventive action) and deviations to support continuous improvement activities. Include root cause analysis as needed.
15. Work with manufacturing to implement quality improvement and efficiency improvements in blending and filling operations and participate in continuous improvement programs.
16. Conduct and manage Annual Product Reviews (APR’s) as needed to support compliance with FDA and Health Canada regulations.
17. Manage and direct the sites’ microbiology/hygiene needs to maintain compliance.

EXPERIENCE:

• Background in lean manufacturing preferred.

Education / Certification / Qualifications / Experience

• BA/BS degree preferred in a field of science required.
• Background with cGMP and FDA compliance required.
• Demonstration of strong detail orientation, organizational skills and the ability to work independently and multi-task.
• Proficient in Word, Excel, and Outlook.
• Must be self-motivated and initiate continuous improvement

1. Lead Management Review Committee and oversee necessary follow up.
2. Perform other duties as required and requested by management.

Education / Certification / Qualifications / Experience

• BA/BS degree preferred in a field of science required.
• Background with cGMP and FDA compliance required.
• Demonstration of strong detail orientation, organizational skills and the ability to work independently and multi-task.
• Proficient in Word, Excel, and Outlook.
• Must be self-motivated and initiate continuous improvement.