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.

Training & Continuous Improvement

• 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).