Supplier Quality Auditor

Job Description

Job Description

Supplier Quality Auditor Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey.

The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors / laboratory services / service providers / manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's 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 and Data Integrity and Eudralex Volume 4 Guidelines.

The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company 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 for company harmonized across all sites.
• Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company 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 within company and 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 review External Auditing, Supplier Qualification and Supplier Management Program and / or Quality Systems SOPs, as needed.
• Ensure that Quality Agreements are generated and enforced at each supplier.
• 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 Quality related support to various departments, as needed.

REQUIREMENTS

• Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry.
• Auditor qualifications and certifications such as Certified Quality Auditor (CQA) / ASQ Certification, ISO Certification, etc.
• 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), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,
• EU and PMDA regulations knowledge and associated guidelines are a plus.
• Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences.
• Certified Auditor or Lead Auditor credentials required.
• 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.
• Must have exceptional written and oral communication skills.
• Exhibit professional mannerisms when dealing with Clients / Suppliers and company personnel
• Ability to multi-task is essential.
• 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.
• Flexible and able to adapt to company growth and evolving responsibilities.
• Multi-disciplinary knowledge across GxP functional areas.
• Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities.
• Good verbal, written communication, and presentation skills.
• Demonstrable multitasking, project management, and execution skills.
• Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence.
• Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors.
• Must have the ability to work in a team-oriented environment and with clients
• Must be able to handle the standard / moderate noise of the manufacturing facility
• Travel required (approx. 50%)

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.