Pfizer Compliance Auditor II in Westport, Missouri
The key role of the Compliance Auditor II is to establish and maintain Supplier Quality and Supplier Compliance oversight to ensure the quality and compliance with Pfizer and Regulatory expectations. In addition, the Compliance Auditor will travel to vendors/suppliers to perform scheduled and ad-hoc or for-cause audits. Compliance Auditor will report findings in a clear, precise and factual way. Will work closely with the Supplier quality department to ensure supplier investigations in response to Supplier Corrective Action Requests and/or Supplier in-house deviations are completed on time and any corrective or preventative actions are put into place in a timely manner. Compliance Auditor will contribute to the continuous improvement of the internal processes and may be asked to participate in Quality related Project teams.JOB DESCRIPTION
• Requires 25% - 75% travel.
• Work with other Compliance Auditors to ensure maintenance of Supplier Oversight Program, including but not limited to Supplier Change Notifications, Supplier Corrective Actions and Supplier Qualifications.
• Act as Quality Compliance / Quality Assurance on the Supplier Compliance Team.
• Monitor performance/compliance issues identified across vendors. Perform Supplier Scorecard assessment and letter issuance on quarterly basis.
• 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. Maintain Questionnaires in SMS and upload to Pfizer Documentation Management System (PDOCs).
• 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 using Pfizer templates, working with Suppliers to meet Regulatory requirements, identification and inclusion of any mitigating responsibilities to ensure compliance, maintain for records.
• Notify management and end users of any issues with Supplier (Poor audit rating or Unapproved status).
• 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: Act as Lead Auditor during supplier audits as needed, travel to suppliers for scheduled and ad-hoc audits. Travel expected 25% - 75%. 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 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.
• Assist with preparation and/or facilitation of regulatory inspections as needed.
• Other duties within the quality department as required.
This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
• Bachelor's degree in a technical field i.e. Biology, Chemistry, Engineering, Pharmacy and a minimum of four years related experience or equivalent combination of education and experience.
• Minimum two years' experience in supplier quality assurance auditing required
• Lead Auditor certification (CQA/ASQ/ISO) preferred
• Knowledge of overall regulatory requirements associated with Quality Systems in pharmaceutical industry required
• Knowledge of Supplier Management System (SMS), and PDOCs preferred
• Knowledge of Medical Devices is an asset
• Fluent in English both speaking &; writing
• Expert skills in document manipulation and electronic document maintenance (e.g. Word, Excel, PowerPoint, SharePoint, Adobe Acrobat) and other data management tools
• Good analytical and investigation skills
• Good interpersonal skills
• Excellent organizational skills
• Good time/task management skills - self-motivated, high throughput
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.