Quality Specialist Methods Coordinator

Description Overview

The Quality Specialist oversees validation protocols and monitoring activities to ensure high quality & performance of analytical methods and testing equipment used in factory control rooms and laboratories at the Gateway facility. Duties include preparation, execution, and documentation of method validations, and rapid method monitoring in compliance to Good Laboratory Practice.  Investigate non-conformance and prepare corrective actions and/or revalidation studies.  Coordinate with key stakeholders across factory and laboratory to successfully execute and document the results of the validation projects.  

Scope of the Role

Quality Management Data

• Administer Regulatory, Safety and Quality Limits for finished product compliance within CAT

Operational Support

• Identify, lead or manage Quality system improvements and investigations

System Compliance 

• Maintain files of all changes made and document technical support
• Conduct compliance against data standards of GLOBE (LIMS)

Quality Guardianship:

• Ensure that method validation work follows relevant company standards.  Prepare calibration/validation/verification studies and protocols and final reports on a timely basis.  
• Manage and monitor the equipment and data of rapid methods to ensure continued compliance with Perrigo’s standards to drive First-Time-Right.
• Comprehend and coach to Good Laboratory Practices, and Laboratory Safety Standards
• Performs equipment / instrumentation acquisition, qualification, and maintenance as needed

Training / Communication:

• Routine communication with Factory Operations, Laboratory team, facility support functions, and external contractors regarding method validation and monitoring activities including sampling, testing & reporting 
• Develop training material, train and coach on the required elements to ensure that operation and laboratory teams generate accurate results and follow Perrigo standards. 
• Drive the development of competence of operators and laboratory technicians and promote quality awareness and commitment.
• Training and coaching of Production operators and QC Technicians in the execution of validation testing protocols, monitoring activities, and improvement needs
• Troubleshoot Globe issues affecting SAP, such as incorrect data entry, inspection plan build errors, lab linking data, etc.
• Coach GLOBE users on data extracts, setting up defaults, apps, and role requests
• Support and update SOPs and Globe site documents (Quick Reference Cards)

Experience Required

Required:  

• Bachelor’s Degree in Food Science, Chemistry, Microbiology, Computer Science or equivalent field.  
• Experience using specification systems and computer data management.  

Preferred:  

• Demonstrated competence in Laboratory Information Management Systems to support business requirements.  
• 3-5 years quality related experience in regulated food manufacturing environment 
• Expertise with Statistics.
• Training and/or experience related to calibration, validation, and verification of analytical or alternative (rapid) methods and project management.