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Pfizer Inc

Compliance Auditor II

Pfizer Inc - Westport, MO

Compliance Auditor II

Pfizer

Westport

MO

Job #663993340

ROLE SUMMARY

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.

QUALIFICATIONS

• 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

PHYSICAL/MENTAL REQUIREMENTS

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.

• Position requires 25% - 75% travel, both within U.S. and abroad, must be able to meet Supplier physical requirements

• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

• Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

• Must be willing and able to work beyond the hours typically defined as a regular workday, which may or may not include weekends and holidays.

• Travel between Brentwood and Westport locations required.

EEO Statement

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.

The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (green card holders), Refugees and Asylees.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Last Date to Apply for Job: May 25, 2018.

Eligible for Relocation Package

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Updated 05/12/2018

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Compliance Auditor II Pfizer Inc - Westport, MO, United States

   

Location: Westport, MO

Company Profile:
Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.