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Supplier Quality Auditor Jobs
Company | PTS Advance |
Address | Lawrence, KS, United States |
Employment type | FULL_TIME |
Salary | |
Category | Staffing and Recruiting |
Expires | 2023-05-11 |
Posted at | 1 year ago |
PTS Advance is looking to speak with Supplier Quality Auditors to join our client who is an established and world-leading pharmaceutical and medical device contract manufacturer in the greater Kansas City, KS area.
In this role, you will oversee the compliance of supplier-related products and services. This position ensures Suppliers meet the company's pharmaceutical requirements and U.S. FDA, Health Canada, ISO and USP, ICH, PDA, and PIC/S standards. Certified Quality Auditor certification is mandatory.
Main Responsibilities
#IND1
In this role, you will oversee the compliance of supplier-related products and services. This position ensures Suppliers meet the company's pharmaceutical requirements and U.S. FDA, Health Canada, ISO and USP, ICH, PDA, and PIC/S standards. Certified Quality Auditor certification is mandatory.
Main Responsibilities
- Serves as the Quality Authority for the selection, development, and approval of new suppliers for new product introductions and assures that strategic initiatives are met.
- Conducts internal audits and maintains the auditor training program.
- Represents the company as the Subject Matter Expert for pharmaceutical supplier quality during regulatory inspections, submissions, and assessments.
- Compiles and assesses supplier metrics (Scorecards) for inclusion in the site and company-wide management review meetings.
- Executes and manages Supplier Quality Agreements and amends as needed.
- Manages the Approved Supplier List.
- Leads the development of a strong partnership with the company's Manufacturing Operations, Quality Assurance, and external suppliers, such as API, excipient, container/closure, packaging, and labeling suppliers and contract testing laboratories and contractors and consultants.
- Manages supplier investigations, CAPAs, complaints, and risk mitigations for commodities that do not meet company specifications.
- Bachelor's Degree from an accredited college or university is required.
- Certified Quality Auditor certification is required.
- 5 years of experience in Pharmaceutical Quality, Manufacturing, Engineering, or R&D functions or any combination thereof, with at least 3 years as a supervisor or manager (preferred).
- Understanding of investigational techniques including problem-solving methodology (5 Whys, Ishikawa diagram, DMAIC, etc.).
- Thorough understanding of Quality Management Systems (Validation, Change Management).
- Knowledge of global cGMP regulations; 21 CFR Parts 210, 211, ISO 9001, ISO 13485, ICH, IPEC Guidelines.
- Direct experience managing external suppliers and third-party manufacturers.
- Must have proven experience with computer software applications to track and trend quality metrics.
- Prior experience with compliance assessments/audit processes.
#IND1
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