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Supplier Quality Auditor

Lynkx Staffing LLC
  • Saddle Brook, NJ
    Today

    Job Description

    Job Description

    Job Description
    Supplier Quality AuditorAllendale, 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.

    Numbers & Facts

    LocationSaddle Brook, NJ

    Skills

    • American Society for Quality (ASQ)unmatched
    • Analysis Skillsunmatched
    • Asepsisunmatched
    • Audit Metricsunmatched
    • Auditingunmatched
    • Bioengineeringunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Business Skillsunmatched
    • Chemistryunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Computer Skillsunmatched
    • Continuous Improvementunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Data Qualityunmatched
    • Detail Orientedunmatched
    • External Auditunmatched
    • FDA Requirementsunmatched
    • File Auditsunmatched
    • File Maintenanceunmatched
    • GCP (Good Clinical Practices)unmatched
    • GLP (Good Laboratory Practices)unmatched
    • Gap Analysisunmatched
    • GxPunmatched
    • Health Information Technologyunmatched
    • Human Resourcesunmatched
    • ICH Regulationsunmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Information Technology/Systems Auditunmatched
    • Interpersonal Skillsunmatched
    • Laboratoryunmatched
    • Laboratory Equipmentunmatched
    • Laboratory Operationsunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Material Auditunmatched
    • Medical Equipmentunmatched
    • Microsoft Excelunmatched
    • Microsoft Officeunmatched
    • Microsoft Outlookunmatched
    • Microsoft PowerPointunmatched
    • Microsoft SharePointunmatched
    • Microsoft Wordunmatched
    • Multitaskingunmatched
    • Negotiation Skillsunmatched
    • Organizational Skillsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Process Validationunmatched
    • Project Executionunmatched
    • Project/Program Managementunmatched
    • Quality Assuranceunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Riskunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Team Playerunmatched
    • Technical Supportunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Vendor/Supplier Evaluationunmatched
    • Vendor/Supplier Managementunmatched
    • Vendor/Supplier Quality Managementunmatched
    • Vendor/Supplier Selectionunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched

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