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Lead Investigator
Lead InvestigatorPfizer, S.A. de C.V • Sanford, NC, US
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Lead Investigator

Lead Investigator

Pfizer, S.A. de C.V • Sanford, NC, US
14 hours ago
Job type
  • Permanent
Job description

Location

United States - North Carolina - Sanford

Overview

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place. To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products. Pfizer, We are one. PGS - Manufacture the Future. Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients.

Use Your Power for Purpose

We are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants regardless of race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We also comply 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. This position requires permanent work authorization in the United States.

What You Will Achieve

  • Investigate quality issues within manufacturing and quality laboratories utilizing Method 1 DMAIC tools (fishbone diagrams, 5 whys, process mapping) as needed to perform root cause analysis.
  • Investigate manufacturing deviations, out-of-specification results, and atypical results.
  • Use your problem-solving skills to identify root causes and suggest effective corrective action plans.
  • Interact and coordinate with appropriate personnel including internal departments, outside vendors, bacterial / viral development QA, regulatory (US / Japan / EU / China), and Qualified Persons during the investigation process.
  • Facilitate cross-functional and cross-site team meetings to perform a thorough investigation. Able to identify root cause, present complex problems with possible solutions, and actively take a leadership role to resolve investigation-related issues.
  • Assess the impact of events on products, equipment, or processes. Communicate with management for all discrepancies that may impact product, and delay disposition or shipments.
  • Propose solutions to identified problems, determine corrective actions and continuous improvements, and assign commitments to facilitate implementation of solutions.
  • Track, trend, and evaluate previous events and assess CAPA effectiveness and impact to current investigation.
  • Draft investigation reports using strong technical writing skills to assure clear, concise summaries, product impact assessments, and related commitments.
  • Collaborate with QA to close investigations and assign responsibility for CAPA commitments.
  • Receive feedback from management and other colleagues, take accountability for actions and personal development.
  • Support regulatory and internal audits by being able to discuss and defend previous investigations.
  • Have a strong understanding of cGMP, Data Integrity and ALCOA principles.
  • Execute and manage multiple initiatives at the same time; use good communication skills to provide updates on investigation status to area management.
  • Ensure all reports comply with regulatory requirements and company policies.
  • Contribute to moderately complex projects, managing your own time to meet targets.
  • Develop plans for short-term work activities within a collaborative team environment.
  • Apply skills and discipline knowledge to contribute to work within the Work Team.
  • Work under general supervision, following established procedures and general instructions.

Minimum Requirements

  • BA / BS with at least 2 years of experience or MBA / MS with any years of experience or associate's degree with at least 6 years of experience or high school diploma (or equivalent) with at least 8 years of relevant experience.
  • Proven record of problem-solving and decision-making skills.
  • Experience in the pharmaceutical industry.
  • Strong background and knowledge in manufacturing, compliance, and technology investigations, processes, and systems.
  • Ability to work both independently and collaboratively.
  • Effective communication skills, both written and verbal.
  • Computer literate with superior skills in managing Excel spreadsheets.

    • Preferred Requirements

  • Master's degree.
  • Experience with investigations, including conducting and writing investigations.
  • Knowledge and experience in Six Sigma and Lean methodologies.
  • Familiarity with regulatory requirements and quality standards.
  • Experience with FDA and EU licensing and inspection.
  • Experience using Documentum systems (such as PDOCS), laboratory information management systems (such as LIMS), learning management systems (such as Plateau, PLS, P2L), inventory management systems (such as SAP), and asset management systems (such as EAMS).
  • Strong analytical and critical thinking skills.
  • Ability to manage multiple projects simultaneously.
  • Experience with root cause analysis and corrective action plans.
  • Excellent organizational skills.
  • Ability to mentor and guide junior colleagues.
  • Strong interpersonal skills and the ability to foster a collaborative team environment.

    • Physical / Mental Requirements

  • Position requirements are typical for an office-based work environment with some shop floor exposure.
  • Perform mathematical calculations and ability to perform complex data analysis.

    • Non-Standard Work Schedule, Travel or Environment Requirements

  • Schedule is primarily day shift (M-F, 8 hrs) but may require off-shift work on occasions.
  • The position requires to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standard Operating Procedures (SOPs) and Pfizer policies and standards.
  • Travel for this position is minimal to none.

    • Benefits and Compensation

    The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver / parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

    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. This position requires permanent work authorization in the United States.

    Work Location

    Work Location Assignment : On Premise. Relocation Assistance : No.

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

    Accessibility

    Pfizer endeavors to make www.pfizer.com / careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and / or interviewing, please email disabilityrecruitment@pfizer.com . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and / or interviewing. Requests for any other reason will not be returned.

    Quality Assurance and Control

    Quality Assurance and Control

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