Drug Product (DP) Compliance Investigator

Company: Pfizer
Location: Kalamazoo
Posted on: May 14, 2022

Job Description:

Why Patients Need YouAt Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. You will work as a coach and a facilitator for improvement projects and establish and maintain performance metrics to measure program success. As an Associate Operational Excellence Investigator, you will support the program by taking care of project governance, project reviews, communications, trainings, certifications and rewards. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues. Your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.ROLE SUMMARYThe Operational Excellence Investigator role will have responsibility for providing real time Method 1/Pfizer Human Performance (PHP) investigations, coaching, execution and support for manufacturing ER/QARs, LIRs and significant safety incidents across the Drug Products organization. This role will have a strong focus on building Method 1 capabilities of colleagues throughout the site that drives and supports the vision of performing thorough investigations and directly supports the PGS transformational objective to reduce repeat QAR's. This role will be involved in the creation and monitoring of metrics and data analysis to identify and drive programmatic approaches that deliver results. Colleagues will inspire, build and support a culture where every colleague is empowered to improve their work every day.Your organizational skills will help us integrate our continuous improvement programs across the organization, both vertically and horizontally. Thanks to your knowledge and skills, the improvement programs will yield stronger results and overall business strategies.ROLE RESPONSIBILITIES

• Support, conduct and coach Method 1/Pfizer Human Performance (PHP) investigations that drive continuous improvement by determining true root cause and recommending appropriate corrective actions.
• Support and build capabilities throughout DP for completing Method 1/Pfizer Human Performance (PHP) investigations that drive to true root cause.
• Collect data and related metrics to share at appropriate site forums.
• Analyze CAPA resulting from site investigations, providing feedback to areas on effectiveness.
• Complete assigned CAPA such as SOP updates, etc.
• Complete projects related to DP Compliance.
• Work with RP and QOP to drive investigations to closure.
• Inspire a culture of continuous improvement by partnering effectively with personnel involved in the investigation process.
• Support the vision of every colleague, every day improving their work processes through a relentless focus on identifying and effectively addressing root cause of incidents.
• Partner with the broader Operational Excellence team to accomplish shared continuous improvement goals related to Lean/Six Sigma, IMEx and other programs.
• Understand and drive compliance with IMEx prerequisites related to investigations.
• Support area managers in their strategies related to M1 investigations and driving to true root cause.QUALIFICATIONS
  • EDUCATION: The successful candidate will have a minimum of 2-5 years of applicable experience and a BA/BS degree in Engineering, Chemistry, Physical/Biological Sciences, Business, Integrated Supply Management, or related applicable discipline that will enable the team to meet its mission.
    • EXPERIENCE: The Ideal candidate must demonstrate:
      • Ability to effectively teach, coach and mentor colleagues
      • Strong oral and written communication skills
      • Ability to work in a team environment
      • Ability to influence others
      • M1 and PHP education and experience
      • Lean Six Sigma education and experience
      • Ability to connect the mission of the team to site goals
      • Knowledge of cGMP(current Good Manufacturing Practices), and manufacturing procedures and standardsGreen/Black belt certification is highly desired.PHYSICAL/MENTAL REQUIREMENTSJob will include standing, walking, sitting, ability to perform mathematical calculations and complex data analysis. Occasional lifting may be required.
        • NOTE: Investigation walkdowns must be performed onsite.Hybrid work schedule is acceptable for the responsibilities of this role.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This is a 1st Shift Position with support to 2nd and 3rd shift production. Job may require occasional weekend/evening work supporting a 24-hour/7 day operation.Relocation support availablePfizer 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 ActPfizer 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 EligibilityPfizer 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.Continuous Imprv and Proj Mgmt

Keywords: Pfizer, Kalamazoo , Drug Product (DP) Compliance Investigator, Other , Kalamazoo, Michigan