Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.
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Description Overview The Quality Control Methods Coordinator 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 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 Release norms. 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 Nestlé 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 Experience
Bachelor's degree required (Chemistry, Food Technology, Biology, Microbiology, Computer Science or other related field)3-5 years quality related experience.
Preferred Experience
Experience using specification systems and computer data management Demonstrated competence in Laboratory Information Management Systems to support business requirements Experience in regulated food manufacturing environment. Training and/or experience related to calibration, validation, and verification of analytical or alternative (rapid) methods and project management. Excellent written and oral communication skills, including report writing. Technical writing ability in an FDA regulated industry and ability to translate technical / quality / compliance theory into practical application. Knowledge of Microsoft Word and Excel is required; SAP and LIMS are preferred. Basic understanding of statistics Working knowledge of FDA and GMP regulations Ability to work independently and translate technical / quality/ compliance theory into practical application. Leadership and people development skills Expertise in microbiological, chemical, or physical analyses Expertise calibration, validation, and verification of analytical or alternative methods Analytical and problem-solving skills; ability to make quick accurate decisions. Ability to prioritize, multi-task and work in fast paced environment. Detail oriented approach to projects and assignments. External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV
