Specialist/Sr. Specialist Quality Contract Manufacturing

Colgate • Topeka, KS

4h • Hybrid

About The Position

The Specialist/Sr. Specialist Quality Contract Manufacturing is part of the global program for contract manufacturing and Quality Standards implementation. Focus includes but it is not limited to the following areas: Coordinate the North American Contract Manufacturing (CM) quality program Support CM operations to incorporate and comply with Global CM Quality Standards Work with S&T to ensure the CM specifications for finished goods and raw materials are updated and in compliance with applicable regulation and the Global CM Quality Standards Drive CMs to action continuous improvement activities Manages and coordinates the execution of the Enhanced Supplier Management program for North America (NA) CMs Supports the Quality representative for the CM Technology Transfer process Support Quality Compliance initiatives as required (Quality standards implementation and auditing programs, etc.)

Requirements

• Bachelor's degree in Food Science, Biology, Chemistry, Engineering or other related field
• 4+ years manufacturing experience in a Food or drug/ cGMP environment
• 3+ years experience in Quality related field
• Working knowledge of FDA regulations, Food Safety, or cGMPs

Nice To Haves

• Masters of Food Science, Biology, Chemistry, Engineering or other related field
• Certification in PCQI, SQF Practitioner, BPCS Certified Auditor
• Familiar with EU/Brazil/Japan/China food regulations

Responsibilities

• Manage the NA region CMs to ensure adherence to Global CM Quality Standards, applicable FSMA regulations, completion and distribution of the site annual management reports, drive continuous improvement, and Quality Technical Agreements.
• Manages the NA region customer complaint investigations. Ensures proper documentation, CAPA, MoC and failure investigations (including microbiological incidents).
• Manages and reports KPI results (Non-conformance, consumer complaints, FG release time, Coman mock recalls, etc.).
• For the NA region, assures acceptable KRSs are reviewed and approved prior to releasing product from the contract manufacturer’s control, as defined and required on Hill’s specifications and regulatory requirements.
• Ensure all product non-conformances are properly investigated, documented and approved by Corporate Quality prior to product release
• Drives completion of the annual CM risk assessments and coordinates the execution of the audit program in NA.
• Ensure that ESM KPIs are met and reported to leadership.
• Provide guidance to maintain CM's audit readiness.
• Participate in the Global Compliance Program, supporting Quality Standards Implementation follow up, participate in the auditing programs (internal audits, supplier audits, corporate audits, FSMA readiness, etc.)
• Ensure that I&S have all CM formulas and specifications updated in the PDM system.
• Ensure the NetOps/Procurement/CS&L formally communicates to the CM the updated formulas and specifications.

Benefits

• medical
• dental
• vision
• basic life insurance
• paid parental leave
• disability coverage
• participation in the 401(k) retirement plan with company matching contributions subject to eligibility requirements
• a minimum of 15 vacation/PTO days
• 13 paid holidays
• Paid sick leave is adjusted based on role and location in accordance with local laws.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level