Our growing, global, Cell Therapy, Regenerative Medicine Client is seeking a Supplier Quality Auditor who will be responsible for ensuring and promoting compliance through external auditing of company suppliers; vendors/ laboratory services/service providers/manufacturers for the NJ and CA sites based on corporate procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7/Q9/Q10, 21 CFR Part 11, current ISO Medical Device Standards; ISO8573, ISO14644, ISO14698, Data Integrity and Eudralex Volume 4 Guidelines. The Supplier Quality Auditor will be responsible for the development of a risk-based auditing program and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites.

• Develop and maintain a risk-based external auditing program harmonized across all sites.
• Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all facilities to ensure complete profile.
• Management of ASL to add suppliers and maintain approval status of all suppliers as needed.
• Based on ASL status, conduct reviews, and perform audits to qualify each supplier used.
• Prepare external audit schedule and conduct audits per the schedule.
• Prepare and complete audit reports and communicate audit information to cross functional teams and the supplier within a timely manner.
• Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures.
• Track audit findings for suppliers to completion and ensure timely closure of audit reports.
• Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity.
• Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers.
• Maintain audit files and ensure all files are properly archived.
• Author and/or review the External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs and revise for best practices, as needed.
• Ensure that Quality Agreements are generated and executed for each supplier, when applicable.
• Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs.
• Assist in other Quality System related responsibilities and provide Supplier Quality related support to various departments, as needed.
• Travel required (approx. 50% - Domestic and International)

REQUIREMENTS

• Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences.
• REQUIRED: Certified Quality Auditor (CQA) or ASQ Certification or ISO Certification, etc. 
• 5-8+ years quality systems auditing experience in pharmaceutical, biologics, or medical device industry.
• Experience with auditing raw materials/excipients, components, and analytical and micro laboratories.
• Proven ability to identify, collaborate, and resolve supplier related compliance issues.
• In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs) 21CFR Parts 210/211, Good Laboratory Practices (GLPs) 21CFR Part 58, ICH Q7/Q9/Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) 21CFR Part 1271, and Data Integrity principles.
• Working knowledge of ISO Standards: ISO8573, ISO14644, ISO14698 are a plus.
• EU and PMDA regulations knowledge and associated guidelines are a plus.
• Understanding of the manufacture and testing of cellular and gene therapies is desirable.
• Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation.
• Experience in Quality Assurance, including the ability to identify and resolve compliance issues.
• Sound knowledge of aseptic processing and supporting technologies.
• Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint.
• Ability to think strategically and tactically (strong detail-oriented).
• Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor.
• Strong analytical and problem-solving skills.
• Multi-disciplinary knowledge across GxP functional areas.
• Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities.
• Good verbal, and written communication, and presentation skills.
  

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines.

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