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.