This position reports to the Site Quality Lead, The Quality Control Specialist will have overall responsibility to manage and control all QC activities in accordance with identified Global Zoetis Quality Systems and Standards as well as all relevant regulatory and legislative regulations across the lifecycle of the Site products.
Direct and oversee analytical activities by providing a Fit for Purpose and Safe working environment in which all equipment and methods are in a validated state and compliant with applicable regulations. Management of the Lab operations includes Testing Management of all Site Materials, Raw Materials, In process and Finished Product Samples, Stability Testing, House Retains, Environmental Monitoring, Utilities, and Microbial testing. Lab management also includes maintenance of laboratory materials necessary to perform testing, maintaining laboratory data integrity, and overseeing laboratory investigations.
Key responsibilities of this position include:
Management of Lab Operations
- Daily batch report review and approval
- External lab management
- 3rd party lab result data entry
- OOS trending and reporting
- Stability testing
- Environmental Monitoring
- Internal Sample Management
- Internal testing
- Laboratory supplies
Audits
- Perform and conduct external audits.
- Production line checks and ATP swabbing to clear production rooms for use
- Assist warehouse team with receiving, logging, and testing (when applicable) returned product
- Expected to maintain all food safety policies and procedures including:
- Wearing clean uniforms, hairnets and beard covers.
- Frequent hand washing and sanitizing.
- Clean latex or neoprene gloves.
- Reporting illness to supervisor or group leader.
- Clean and sanitize tools and equipment.
- Storing tools and materials in their designated place.
- Exceptional organization and housekeeping practices.
- Vigilant food allergen practices and procedures to prevent cross contact contamination.
- Reporting any food safety concerns to prevent potential contamination and food safety hazards.
- Diligently monitoring critical control points in accordance with our food safety plans.
Internal Lab Management
- Obtain testing and retention samples from bulk containers of raw ingredients and finished products.
- Prepare sample dilutions for microbial analyses using 3M Petri film and manage associated inventory necessary to complete microbial analyses.
- Perform organoleptic testing on powder, liquid, and food components.
- Perform a variety of laboratory analyses including FT-IR spectroscopy, bulk density, loss on drying, refractometry, Water activity, and pH measurement.
- Maintain FT-IR spectral library.
- Maintain accurate records of all testing performed in a manner consistent with GMP regulations.
- Ensure laboratory equipment is maintained and calibrated according to the maintenance schedule.
- Assures that products conform to established specifications of purity, quality, and composition.
Standardized Testing
- Works with Site Quality Leader to establish in-house assay methods and criteria for assays from independent laboratories.
- Keep all product file information current and up to date.
- Makes recommendations to improve Product Quality/Product Assurance/GMP standards.
- Create relevant and appropriate laboratory SOPs.
- Create various specification documents.
- Assist with various activities relating to regulatory compliance.
- Printing Raw Material Disposition certificates, clearing raw material for use
- Green tagging Finished, WIP, and raw materials for use or shipping
- Reviewing, testing, and approving Finished, WIP, and raw materials for use and their associated batch reports
- Sampling of raw materials in accordance with GMPs, as they are received in warehouse
- Maintaining all documents associated with FDA, and GMP compliance
- Assist with disposition decisions of all materials, production line clearings, etc.
- Supports the implementation of the Food Safety Culture Program
- Other QA/QC related tasks
Staff and Leadership Responsibilities:
- Stewardship of the Quality Culture within the Quality Operations Function as well as the Site.
- Support the development of Quality goals and targets as part of the organization’s strategic plan.
EDUCATION AND EXPERIENCE
- Bachelor of Science in Food Science, Food Technology, Biological sciences, Chemistry, or other related sciences.
- Demonstrated knowledge of compliance, quality and scientific principles in a Life Science environment is required.
- Environmental Monitoring experience preferred
- Minimum of 5 years progressive experience in the quality control.,
- Detailed knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Lean Six Sigma Qualification (Green Belt or Black belt) desirable.
TECHNICAL SKILLS and COMPETENCIES REQUIRED
- Fluency in quality systems and regulatory compliance.
- Driven / Passionate about Quality performance and delivering results.
- Must have strong communication skills to nurture our food safety culture.
- Must be well-organized, detail oriented, and able to work within deadlines as well as under pressure.
- Exercises Good Judgment and Drives Change– using appropriate influence techniques.
- Strong written and oral communication skills as well as negotiation skills
- Confident decision maker, self-accountability with an ability to develop and adhere to self-directed standard work.
- Drives for Superior Results
- Inspires Continuous Improvement and Breakthrough Thinking – utilizing problem solving tools such as Lean and Six Sigma
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with Quality and Business objectives
- Fluent in English (written and spoken).
- Demonstrated written communication skills, as well as experience with presenting to leadership teams.
- Business Fluency and awareness and Ability to be a Trusted Partner.
PHYSICAL POSITION REQUIREMENTS
- This is full time position based at the Site.
- This position will require fluent use of teleconferencing tools, as well as Sharepoint technologies and MS Office tools, to share and manage information
