GMP Investigations Specialist — Manufacturing Quality

Pfizer; Kentucky; On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

401(k) match

Health benefits

Vacation & leave

Relocation assistance

Job summary

Pfizer in the United States is seeking a GMP Investigator to lead and author investigations within our quality systems, focusing on manufacturing deviations and product quality events. You will work with cross-functional teams to determine root causes and drive CAPAs to closure.

You will collect data from manufacturing records, lab data, and audit trails, ensuring timely, compliant investigations and robust documentation across processes.

Qualifications

• Bachelor's degree with 0–2 years of relevant experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience.
• Strong technical writing and documentation skills with demonstrated ability to author complex GMP records.
• Experience in a GMP biotechnology manufacturing or laboratory environment.
• Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions.
• Excellent organizational and project management skills with the ability to independently manage multiple priorities and deadlines.

Responsibilities

• Lead and author GMP investigations within Pfizer quality systems for manufacturing deviations, product quality excursions, equipment and facility events, and compliance-related observations.
• Conduct thorough fact-finding, data collection, and technical assessments utilizing manufacturing records, process data, laboratory data, audit trails, equipment histories, and enterprise systems.
• Facilitate cross-functional investigation teams to identify root causes using structured problem-solving methodologies and quality risk management principles.
• Partner with Manufacturing, Quality Assurance, Process Development, Engineering, Validation, and Analytical teams to determine event impact, product disposition requirements, and corrective/preventive actions.
• Drive investigations to completion while ensuring quality, regulatory compliance, and adherence to established timelines.
• Evaluate investigation trends and support continuous improvement initiatives aimed at reducing repeat events and improving manufacturing robustness.
• Support internal and external audits, regulatory inspections, and quality system assessments as required.
• Contribute to additional quality and compliance initiatives, including audit responses, CAPA effectiveness evaluations, risk assessments, and procedure development.

Skills

Technical writing

GMP experience

Data analysis

Project management

Education

Bachelor's degree

Associate's degree

High school diploma with 6 years experience

Job description

Pfizer in the United States is seeking a GMP Investigator to lead and author investigations within our quality systems, focusing on manufacturing deviations and product quality events. You will work with cross-functional teams to determine root causes and drive CAPAs to closure.

You will collect data from manufacturing records, lab data, and audit trails, ensuring timely, compliant investigations and robust documentation across processes.