Kansas Works Jobs

Kansas Works Logo

Job Information

Pfizer Sr. Customer Quality Operations Professional in McPherson, Kansas

Why Patients Need you

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Senior Customer Quality Operations Professional is the sole responsible colleague for providing quality support related to PGS McPherson Pfizer CentreOne contract manufacturing customers. Responsible for both new business and commercial accounts. Colleague will be required to support multiple customers, can multi-task through each customer issue/requests, work with site SMEs for each activity as needed and represent Pfizer in a professional manner.

This position functions as a member of the Quality Assurance Internal & External Supply Group that supports quality assurance for the site, suppliers that support the site and Customers that the site contract manufactures for. This individual will act as Project Lead for Quality Systems to collaborate with customers and cross-functionally throughout the facility to ensure delivery of Quality Product for our Customers. This role will also have additional responsibilities to drive systems for the team and act as oversight for Customer Quality Operations Professionals on the team.

How You Will Achieve It

  • Lead discussion with Customers on the Quality aspects of all manufacturing processes specific to assigned Pfizer CentreOne customers. These processes include but are not limited to supplier qualification, manufacturing, packaging, lab testing, release, shipping, market distribution, complaints, regulatory filings and market action.

  • Quality Project lead for all contract reviews, creation of new quality technical agreements, assurance of site capabilities as it pertains to quality processes, understanding of development activities and identification of issues for escalation and initial quality audits.

  • Oversee systems of Continuous Improvements for Customer Quality Operation Professionals and additional responsibilities to drive performance.

  • Lead Quality Resource for new customer due diligence meetings and quality audits.

  • Responsible for Quality assessment of all new customer proposals.

  • Develop and Trend quality metrics for each individual Pfizer CentreOne customers. Project lead for areas for improvement through the metrics and driving continuous improvement opportunities to present to the customers and implementation.

  • Draft, negotiate, and gain approval of the Quality Technical Agreement between Pfizer and the customer.

  • Ensure the terms within the agreement are met by both parties. Perform a periodic review of the agreement and update as required.

  • Provide support for and coordinate Pfizer CentreOne customer manufacturing investigations. This will include assessment of scope, input of customer specific information/data, quality impact, escalation and review/approval.

  • Perform communication, tracking and closure of manufacturing investigations, change requests and CAPAs for Pfizer CentreOne Customer specific records.

  • Responsible for quality escalation and issue resolution as it impacts assigned Pfizer CentreOne customers.

  • Support and participate in customer audits and regulatory inspections.

  • Lead Projects between Pfizer CentreOne customers and plant quality functions specific to assigned customers.

QUALIFICATIONS

Must-Have

  • Applicant must a High School Diploma (or Equivalent) and eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor's degree with at least three years of experience; OR a Master's degree with more than one year of experience.

  • Degree should be in Engineering, Science, Business or related field.

  • Prior experience in the pharmaceutical and/or manufacturing industry, preference in documentation, Quality, and/or Quality Systems (i.e., QTS, PDOCs, etc.).

  • Strong oral and written communication, presentation and interpersonal skills.

  • Working knowledge of PC and Software (MS Office).

  • Strong analytical skills required. Must be capable of organizing and analyzing data from multiple sources and extracting key information to achieve goals.

Nice-to-Have

  • Industry experience with an understanding of cGMP Requirements

  • Previous experience in internal assessment program, auditing, and/or walkthrough audits

  • Production operations and/or Laboratory knowledge preferred

PHYSICAL/MENTAL REQUIREMENTS

  • Must be capable of interfacing with multiple levels of people within the organization and across the network, including Corporate Management, third party customers, and site colleagues at all levels.

  • Will require on site presence, may include walking throughout site to support Regulatory Inspection activities.

  • Requires tactful, persuasive, and assertive interpersonal skills and the ability to work both independently and with teams.

  • Requires training for controlled environments within the facility to help facilitate walkthroughs audits.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • This role is standard day Monday through Friday work shift; Infrequent off-shift hours may be needed

  • < 20% Travel may be required.

Other Job Details

  • Work Location Assignment:On Premise

  • Last Date to Apply: October 4, 2022

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

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 as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

#LI-PFE

DirectEmployers