Manager - Quality Assurance & Compliance-NL Quality Control

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.

QUALITY ASSURANCE & COMPLIANCE MANAGER

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.

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.

Experience:

• Background in lean manufacturing preferred.
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Physical Demands

• Stand 20% of the time.
• Sit 80% of the time.
• Use hands to finger, handle or touch 100% of the time.
• Reach above shoulders less than 10% of the time.
• Climb or balance less than 10% of the time.
• Talk or hear 50% of the time.
• Taste or smell up to 10% of the time.
• Lift up to 50 pounds up to 5% of the time.
• Close Vision (clear vision at 20n inches or less).
• Color Vision (ability to identify and distinguish colors).
• Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).

Tools/Equipment Used:

• Use the computer up to 95% of the time.
• Use the copier less than 5% of the time.
• Use the telephone up to 10% of the time.
• Use of various lab equipment 50% of time.

Work Environment/PPE Required 

• Work near moving mechanical part less than 5% of the time.
• Work in high, precarious places less than 5% of the time.
• Exposed to fumes or airborne particles up to 10% of the time.
• Risk of electrical shock less than 5% of the time.
• Work/job related travel less than 5% of the time.
• Moderate noise.

KDC-ONE is an equal opportunity employer and does not discriminate on the basis of race, religion, color, national origin, age, sex, gender, disability or any other characteristic protected by law. I understand that employment with KDC-ONE Company is at-will, meaning that I or KDC-ONE Company may terminate my employment at any time, or for any reason consistent with applicable state or federal law. I understand that KDC-One requires the successful completion of a drug and/or alcohol test as a condition of employment.