Vendor Quality Auditor
St. Louis, MO
$70 – $90/hr W2
This position is responsible Vendor Quality Auditor will ensure realization of the site vendor oversight plan by conducting risk assessments, paper based audits and ensuring the follow-up on corrective actions. Vendor Quality Auditor will report your findings in a clear, precise and factual way. Will work closely with departments outside QA to improve overall quality and oversight of vendors. Will work closely within the Vendor Quality Management department to ensure assessments and follow up actions are completed on time and any corrective or preventative actions are put into place in a timely manner. Vendor Quality Auditor will contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams.
· Work with other Compliance Auditors and different departments to ensure maintenance of Supplier/Vendor Oversight Program.
· Perform paper based vendor audits
· Monitor performance/compliance issues identified across vendors. Perform Supplier Scorecard assessment and letters
· Participate and/or lead cross functional meetings and process improvement teams related to supplier improvement.
· Supplier Selection Process: Determine acceptability of suppliers for potential use by Pfizer. Act as Quality Authority for approving Supplier Evaluation Reports, completing Supplier Assessments. Issue Material Safety Risk Questionnaires (MSRQ) to suppliers, review and approve responses, including BSE & TSE statements.
· Supplier Qualification Evaluation: Act as Quality Authority or author Supplier Qualification Summary Reports.
· Supplier Quality Risk Management: Review and approve Supplier Corrective Action Requests, responses and proposed corrective and preventative actions. Work with Pfizer Meridian Quality Engineers to ensure corrective and preventative actions are implemented. Perform impact assessments for Supplier Change Notifications, assigning additional departments to the review as needed. Manage Supplier Quality Agreements, which includes preparing Quality Agreements, working with Suppliers to meet Regulatory requirements, identification and inclusion of any mitigating responsibilities to ensure compliance, maintain for records.
· Complete Risk Assessments for vendor oversight, qualification, audits, etc.
· Notify management and end users of any issues with Supplier.
· Supplier Master List: Manage Approved Supplier List in Pfizer’s Supplier Management System (SMS), including but not limited to: Supplier Name, Address, Supplier Role, Supplier Chain Management, Supplier Contacts, product codes. Approve Supplier Qualification and Approve Supply Chains in SMS.
· Supplier Quality Oversight: Assist with preparation for supplier audits to include review of Scorecard, manufacturing deviations, product recall or reprocessing, or change controls associated with the supplier. Work with other sites using supplier to ensure full coverage and inclusion during audit. After paper based audit completion provide a clear, precise report for Quality review. Supplier Audit reports are to include audit rating as well as reference to standard, regulation or Quality Agreement expectations or requirements (e.g. 21CFR210, ISO 9001, etc.)
· Work with Pfizer Global Supply groups (center functions, other sites) as needed: Manufacturing & Supplier Quality Assessments (MSQA) Team, other Pfizer site Supplier Compliance Groups, Procurement, etc.
· Other duties within the quality department as required.
· Bachelor’s degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum five (5) years of experience in a pharmaceutical and/or medical device production environment or equivalent combination of education and experience.
· Knowledge and understanding of ISO 13485, ISO 14971, and 21 CFR 210, 211, & 820
· Strong auditing experience in medical device, pharmaceutical and/or contract manufacturing required
· Lead Auditor certification (ASQ/CQA/ISO) preferred
· Experience with Risk Assessments preferred
· Excellent analytical and investigation skills
· Fluent in English both speaking & writing
· Good interpersonal skills
· Excellent organizational skills
· Excellent self-management, time management, and problem solving skills – predict problems and find solutions
· Ability to be flexible, resilient, and adaptable to changing priorities in a fast paced, high pressure environment.
· Exercise sound judgment and ability to work effectively with a diverse workforce.
Talent Acquisition Lead
ComTec Information Systems, Inc.
5525 North MacArthur Blvd., Suite 650
Irving, TX 75038