QA/ QC Compliance Analyst

Phibro Animal Health Corporation

West Virginia

On-site

USD 75,000 - 114,000

Full time

12 hours ago
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Job summary

Phibro Animal Health Corporation in Willow Island, WV is seeking a dedicated Quality Compliance Specialist to support quality compliance systems and drive continuous improvement across manufacturing and warehouse activities.

You will collaborate with Quality Control, Production, and Regulatory Affairs to ensure adherence to cGMP and CFR standards, assist in audits, CAPA, and training, and lead documentation control and SOP development.

Qualifications

  • BS degree in a scientific field; preferred.
  • Minimum of 2 years of related experience, preferably in an FDA-regulated industry.
  • Fundamental understanding of cGMP regulations and global regulatory standards.
  • Willingness to travel (~10% domestic).
  • Ability to work independently.

Responsibilities

  • Provide quality and compliance oversight for manufacturing and warehouse activities, including on-the-floor support to assess deviations and incidents.
  • Support the release of finished goods documentation, including COA, labeling, and batch records reviews.
  • Facilitate CAPA plans and investigations; coordinate and investigate customer complaints.
  • Maintain compliance tracking systems and archive records; assist SOP development.
  • Prepare the site for FDA, USDA, and other audits and assist in remediation plans.
  • Educate and mentor employees on quality system requirements and cGMP standards.

Skills

Written and oral communication
Attention to detail
Time management
Problem solving
Interpersonal skills
Travel willingness

Education

BS degree in a scientific field

Tools

Microsoft Office

Job description

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About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,400 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

TheQA/ QC Compliance Analystis an integral part of our Qualityteam based out of our US - Willow Island, WVsite.

Compensation range for this position is $74,880.00 - $114,400.00

Position Summary

We are seeking a dedicated Quality Compliance Specialist to support quality compliance systems and objectives at our Willow Island, WV site. In this role, you will maintain a quality mindset, drive continuous improvement, and implement quality initiatives in accordance with industry and regulatory requirements. You will collaborate closely with cross-functional teams, including Quality Control, Production, and Regulatory Affairs.

Key Responsibilities

Quality Oversight & Compliance Management

  • Provide quality and compliance oversight for manufacturing and warehouse activities, including on-the-floor support to assess deviations and incidents.
  • Support the release of finished goods documentation, including technical reviews of batch records, labeling, Certificates of Analysis (COA), reprocessing instructions, and lot deviations.
  • Facilitate and implement Corrective and Preventive Action (CAPA) plans.
  • Coordinate and investigate customer complaints.
  • Maintain and monitor compliance tracking systems and archive records (e.g., document control, deviation reporting, calibration, records retention/destruction).
  • Assist in developing and editing Standard Operating Procedures (SOPs), forms, flow diagrams, and specifications.

Auditing & Regulatory Support

  • Prepare the site for FDA, USDA, and other regulatory compliance audits; assist in developing remediation plans and regulatory responses as needed.
  • Conduct internal compliance, surveillance, and focused audits (audit plan development, technical documentation review, risk identification, and final reporting).
  • Perform vendor and supplier quality audits to ensure incoming material and service quality.
  • Provide Regulatory Affairs compliance support for submissions, approvals, product labeling, and registrations.
  • Interpret and communicate regulatory requirements (cGMP, CFR, etc.) as they relate to company products and operations.
  • Educate and mentor employees on quality system requirements, compliance expectations, and cGMP standards.
  • Develop training modules and conduct new hire, cGMP, and refresher training courses.
  • Continuously drive internal process and product improvements with a strong quality mindset.

Technical & Engineering Reviews

  • Perform technical reviews and approvals for validation documents, design reviews, engineering reviews, IQ/OQ/PQ, protocols, and project reports.
  • Provide compliance guidance for new/existing processes, facilities construction, installation, and design reviews.
Qualifications and Experience Requirements

Level I Requirements:

  • Education: BS degree in a scientific field preferred.
  • Experience: Minimum of 2 years of related experience, preferably in an FDA-regulated industry.
  • Knowledge: Fundamental understanding of cGMP regulations and global regulatory standards.
  • Skills: Strong written and oral communication skills; ability to work independently.
  • Travel: Willingness to travel (~10% domestic, occasional international).

Level II Requirements:

In addition to Level I requirements:

  • Experience: Minimum of 5 years of related experience in an FDA-regulated industry.
  • Track Record: Demonstrated success interacting with senior management, external audit groups, and regulatory bodies (e.g., FDA, USDA).
  • International Experience: Familiarity with Canadian, EMEA, or Latin American regulatory regions desired.
  • Certifications: Certified Quality Auditor (CQA) preferred.

Core Technical & Soft Skills

  • Strong interpersonal skills with the ability to communicate effectively across all levels of the organization and with external vendors/customers.
  • Exceptional attention to detail and strong time management skills.
  • Creative problem-solving capabilities to accomplish tasks while balancing timelines and budget constraints.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit:Animal Health & Mineral Nutrition
Division:Animal Health & Nutrition
Department:Quality
Location:US - Willow Island, WV
Work Schedule:Monday - Friday (Standard Work hours)

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