Supplier Quality Auditor
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20167-AB1
Compensation : 100000.00 - 115000.00 USD/YEAR
Start Date : 10/02/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Biotechnology
Job Description :
- Permanent position for a Supplier Quality Auditor to provide external auditing of supplier manufacturers, laboratory and other service providers to ensure compliance to procedures, FDA and other regulatory requirements.
- Author and review External Auditing, Supplier Qualification and Supplier Management Program and Quality Systems SOPs.
- Conduct external supplier, vendor and manufacturer audits.
- Standardize and integrate the supplier qualification process across all sites.
- Interface with all sites to support all qualification initiatives, continuous improvement, and regulatory compliance.
- Conduct GAP analyses of the Approved Supplier List at all sites to ensure complete profile. Conduct reviews and audits to qualify each supplier on ASL approval existing and add new suppliers as needed.
- Prepare external audit schedule and conduct audits.
- Prepare and complete audit reports and communicate results internally to other groups.
- Track audit findings for suppliers to completion and ensure timely closure of audit reports.
- Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures.
- Serve as quality lead and liaison between suppliers and internal teams to identify issues that may impact quality, system gaps or cause business interruptions.
- Maintain metrics on supplier audit findings used for oversight, qualification status, and continuous improvement.
- Generate and enforce Quality Agreements at each supplier.
Required Qualifications :
- BS Engineering or Science
- Minimum 5 years quality systems auditing experience in the pharmaceutical, biotech, or medical device industry.
- Certified Auditor or Lead Auditor (CQA)/ASQ Certification required.
- Experience with auditing raw materials and components as well as analytical and micro laboratories.
- Experience in Quality Assurance, including the ability to identify and resolve compliance issues.
- Proven ability to identify, collaborate, and resolve supplier related compliance issues.
- In-depth knowledge and understanding of cGMPs, GLPs, and Data Integrity principles.
- Sound knowledge of aseptic processing and supporting technologies.
- Knowledge of EU and PMDA regulations is preferred.
- Understanding of cellular and gene therapies is preferred.
- Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation.
- Computer proficiency including MS Office and SharePoint.
- Travel required (approx. 50%)
Contact: Allan Berman
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