- Authorize release or reject of product and product components.
- Provide oversight for the following systems: document control, label control, calibrations, change control, environmental monitoring, stability, and preventative maintenance.
- Complete thorough and well documented investigations. Draft, review, and approve associated documentation: Out of Trend Investigation Report, Laboratory Investigation Report, and Non-Conformance Investigation Report.
- Maintain critical chemical inventory and instrumentation support to assure uninterrupted operation of the analytical laboratory.
- Draft, review, and approve new or revised Standard Operating Procedures.
- Draft protocols and summary reports for qualifications, verifications, and validations.
- Draft Master Batch Record revisions.
- Analyze QA and QC data for trends, performance issues, and potential opportunities for improvement.
- Implement programs to measure and improve quality metrics.
- Design and implement training programs for Quality and Manufacturing teams aimed at improving product quality and efficiency.
- Present monthly Quality Review to management team.
- Participate in audits and inspections: FDA, DEA, KY Board of Pharmacy, ISO 9001, internal, customer, etc.
- Assist in the preparation of regulatory submissions
- A Bachelor's degree from a four-year college or university
- 5 or more years of related experience and/or training is required.
- Ability to develop and run compliant analytical methods.
- Qualified as an ISO internal auditor.
- Technical writing experience is a must
- The ideal candidate will have a working knowledge of 21 CFR Parts 210/211, as well as ISO 9001 and DEA List I Chemicals
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Quality Manager - Lexington, United States - Neogen
Description
Come Be Part of a Mission that Matters
Neogen Animal Safety Division is currently seeking to hire a Quality Manager who will be responsible for providing leadership within the Quality Control Unit to ensure support of manufacturing operations.
DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Education and/or Experience:
WHO IS NEOGEN:
From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our animal safety solutions are used on farms, veterinary practices and manufacturers around the world to provide the best animal care possible. Whether food or pharmaceuticals, Neogen's provides a one-stop shop for the health and safety to our animals and our customers operations.
Neogen's culture combines stability with a deep belief in providing professional and personal growth. Our Pillars of Trust — the principles that guide our everyday decision-making, include Openness, Honesty, Credibility, Respect, and Service . It's our belief in these characteristics that provides a consistent, happy and healthy work environment for our employees.
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