Quality Specialist II

Posted 13 Days Ago
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Lexington, KY, USA
In-Office
Junior
Biotech • Pharmaceutical
The Role
The Quality Specialist II will support Quality Systems management through corrective actions, documentation, training, and compliance to ISO standards and cGMPs.
Summary Generated by Built In
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Quality Systems Specialist

We are seeking an individual to support Quality Systems management by executing various activities such as corrective actions, batch record reviews, documentation maintenance, supplier quality, and audit program administration. This role ensures compliance with ISO standards, cGMPs, and customer expectations while providing training and support for quality policies and procedures.

Schedule: Monday - Friday, 2nd shift (2:30 PM - 11:00 PM

Responsibilities:
  • Utilize and monitor manual and software programs within the quality management system.
  • Identify areas requiring additional quality support or corrective/preventative actions.
  • Provide training and support on quality systems, policies, and procedures.
  • Assist in maintaining and communicating company quality policies and procedures.
  • Issue and audit batch records and manufacturing procedures.
  • Assist in ISO and internal audits as needed.
  • Support the writing of SOPs, product standards, and batch records.
  • Maintain documentation related to change control, operations, batch records, training, validations, calibrations, and qualifications.
  • Troubleshoot and provide real-time quality support to operations.
  • Compile data to support quality trending programs.
  • Enforce compliance with product batch records and standards.
  • Assist QC personnel in releasing incoming raw and packaging materials.
  • Support investigations on minor nonconformances.
Qualifications:
  • High school diploma or GED required; additional education is desirable.
  • 1-3 years of related experience or an equivalent combination of education and 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.

Top Skills

Cgmp
Iso Standards
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The Company
HQ: Lansing, MI
1,160 Employees
Year Founded: 1982

What We Do

NEOGEN Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases and sanitation concerns. NEOGEN’s Animal Safety Division markets a complete line of diagnostics, veterinary instruments, veterinary pharmaceuticals, nutritional supplements, disinfectants and rodenticides.

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