Location: Eau Claire,WI, USA
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.
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.
Description Overview
This position plans, coordinates, and executes quality control activities to ensure continued function and high performance of the laboratory. Maintains open line of communication with key stakeholders to identify and direct priorities for the team.
Ensures the proficiency and optimal functioning of the factory laboratory in order to provide the best analytical services. The position is responsible for ensuring Good Lab Practices (GLPs) are in place per regulatory requirements including but not limited to standard operating procedures, instrument validation and calibration, change control and development of technical expertise in laboratory systems.
This position will work autonomously under the supervision of the Senior Quality Manager.
This is a 1st shift opening
Scope of the Role
* People and Know-How - Provide leadership, development, and support to maintain competent professionals in the laboratory and online satellite laboratory areas. Hire, coach, evaluate and direct Laboratory Employees in the Quality Control Laboratory. Routine communication with Factory Operations, Internal support functions, and external contractors in facilitation and planning of laboratory operations.
* Laboratory Methods and Practices - Responsible for the effective, compliant and cost-efficient functioning of the laboratory and online satellite laboratories, including availability of equipment, internal and external quality control. Validate and establish new and existing methods according in compliance to the FDA requirements. Coordinate completion of qualification / validation / verification protocols. Select, organize and follow up analyses performed by subcontracted labs. Support factory in implementing method updates, alternative methods and in establishing monitoring plans. Ensures accurate and high-quality analysis by application of validated methods as verified by routine performance testing. Conducts investigation and gap closure for relevant audit gaps and laboratory deviations. Facilitates equipment / instrumentation acquisition, qualification, and maintenance.
* Quality System - Responsible for the proper implementation and regular update of the laboratory quality system in accordance with the Regulatory and ISO standards. Responsible for the management of the Shelf Life, Stability and Finished Product compliance monitoring programs. Provide support for validation activities from an expert standpoint (Physio-Chemical, Microbiological,).
* Quality Guardianship - Support unit readiness for internal and external audits. Responsible for the adequate follow-up on results of proficiency tests and inter-laboratory comparisons. Able to identify and interpret analytical results and trends. Responsible for performing root cause analysis in case of unacceptable results and in applying corrective action. Oversee completion of periodic maintenance and calibrations of analytical instrumentation and equipment. Prepare, review, and audit reporting results for Chemical, Nutritional, Microbiological, Commercial Sterility, Nutrient Stability, and Raw & Packaging Material Inspections/Qualifications.
* Quality by Design - Support during industrialization and launch steps of projects from an analytical standpoint.
* Laboratory Safety - Responsible to ensure a safe work environment for the technicians who work in and the individuals who visit the laboratory areas. Provides subject matter expertise and coaches to Good Laboratory Practices, Laboratory Safety Standards, and Biosafety/Biosecurity Protocols.
Experience Required
Academic Experience
Required: Bachelor's Degree or equivalent (preferred microbiology, chemistry or food science)
Preferred: Master's of Science or MBA.
Business Experience
Required: 3+ years in quality supervision role in a manufacturing environment.
Required: Minimum of 3 years Quality Control Experience
Preferred: Experience in Infant Formula or Pharmaceutical industry.
OTHER SKILLS
* Demonstrated leadership and development skills
* Organizational strategy skills and ability to work under pressure
* Service-oriented attitude
* Ability to prioritize, multi-task and work in a fast-paced environment.
* Demonstrated ability to lead and coach others
* Lab analytical skills
* Detail-oriented
* Budgeting skills
* Expertise in microbiological, chemical and nutritional analyses, in-line testing and inspection
* Problem-solving skills; ability to make quick accurate decisions
* Knowledge of Microsoft Word, Excel, is required; SAP experience is preferred
* Experience with SPC/ match/ statistical inference
* Ability to work flexible hours
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
Nearest Major Market: Eau Claire