Quality Compliance Team Leader

Lawrence, KS

Posted: 04/12/2019 Industry: Laboratory - Food & Beverage Job Number: 165.19JF Pay Rate: 100,000 - 125,000

Quality Compliance Team Leader

The Compliance Team Leader is responsible for developing, implementing and monitoring the manufacturing site’s quality systems and regulatory compliance:

Regulatory Compliance:  Understands and influences the implementation of all plant, company and government standards for Food Safety, HACCP, GMP’s and FSMA initiatives

Documentation / Communication:  Lead, implement, monitor and control the Document Control programs that assure all documents related to the product quality meet the requirement of the 26 Global Quality Standards, Good Manufacturing Practices (cGMP), Food Safety / Preventative Controls Program, Pre-requisite Programs, and FSMA requirements

Standardization and Training:  Delivers company’s quality training of SOP’s and Quality Standards to the site and ensures proper implementation to the plant personnel.  Ensure the Validation Program, Calibration Program, and associated protocols are in compliance with regulatory requirements and are followed.  Monitor and report Customer Complaint trends and history.  Ensures all complaints are fully investigated and documented

Continuous Improvement:  Lead the continuous improvement of the site in creating and maintaining an Internal Audit Program, Management of Change, Corrective & Preventative Action, and Non-conformance program to improve Food Safety and cGMP compliance at the site

Product Release:  Supervise product release process to ensure all documents related to production are reviewed for all finished product release criteria, HACCP and cGMP compliance prior to release

Responsibilities:

  • Ensure site adheres to company Standards and company’s Food Safety Program. Includes implementing and maintaining a documentation system with metrics in compliance with cGMP’s / FSMA requirements
  • Ensure proper execution of Product Release program to meet Standards
  • Investigates and manages customer complaint issues and drives continuous improvement at site level
  • Responsible for creation and management of plant quality Internal Audit programs which also consist of KPI communication & Forward Action Plan tracking
  • Facilitates follow up and closing verification in compliance with Quality Standards and applicable regulations of all Internal and external audit findings and CAPA program
  • Responsible for managing the execution of the CAPA / Non-conformances programs to meet the expectations of the standards
  • Responsible for internal MOC processes and ensure calibration program is executed on a timely manner
  • Updates Regulatory documentation to support compliance for site portfolio
  • Ensure site conducts proper validation testing and documentation to any process changes impacting company’s products and processes
  • Direct & schedule work, conduct performance appraisals, conduct training and manage work performance of non-exempt / non-supervisory Quality personnel

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Jeff Fee at jfee@cps4jobs.com.

JO:  165.19JF
#LI-JF1

Requirements:

  • MS Food Science, must have MS, prefer PhD Food Science, Chemistry, Engineering, Biology or other related technical fields
  • 5+ years of manufacturing experience in a Food or Drug / GMP environment
  • 3+ years in Quality related field
  • 3+ years in supervisory experience
  • Knowledge of FDA regulations
  • Experience in managing regulatory inspections
  • Excellent analytical and problem-solving skills
  • Clear and effective communication
  • Knowledge of Auditing
  • Ability to quickly learn and utilize computer applications, i.e. Windows, SAP
  • Demonstrates the ability to influence change within the organization
  • Knowledge of HACCP, Food Safety, FSMA, Statistical Process Controls
  • Extensive knowledge of company standards and systems
  • Certification in HACCP or Food Defense
  • Certified Auditor
  • SAP experience

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Jeff Fee at jfee@cps4jobs.com.

JO:  165.19JF

#LI-JF1

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