GMP Investigations Associate — Quality & Compliance

MedDeviceJobs; Andover (MA); On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

401(k) matching

Paid vacation and holidays

Comprehensive health benefits

Job summary

Pfizer is seeking a Quality Investigator to lead GMP investigations in manufacturing settings in the U.S. This role demands strong technical writing, data analysis, and cross-functional collaboration to drive CAPAs and ensure compliance.

The candidate will partner with QA, Process Development, Engineering, and Validation teams to determine impact and corrective actions, while supporting audits and inspections as needed.

Qualifications

• Bachelor’s or equivalent with GMP exposure.
• Strong technical writing and documentation.
• Experience in GMP biotechnology manufacturing or labs.
• Ability to analyze data and identify trends.
• Excellent organization and project management.

Responsibilities

• Lead and author GMP investigations within Pfizer quality systems.
• Collect data and assess manufacturing records and lab data.
• Facilitate cross-functional investigation teams for root cause analysis.
• Collaborate with QA, Process Development, Engineering to determine actions.
• Support audits and regulatory inspections.
• Contribute to CAPA, risk assessments, and procedures.

Skills

GMP investigations

Technical writing

Data analysis

Project management

Cross-functional teams

Education

Bachelor’s degree

Associate’s degree

High school diploma

Tools

DeltaV

SAP

LIMS

Microsoft Dynamics

Electronic batch records

Document management

Job description

Pfizer is seeking a Quality Investigator to lead GMP investigations in manufacturing settings in the U.S. This role demands strong technical writing, data analysis, and cross-functional collaboration to drive CAPAs and ensure compliance.

The candidate will partner with QA, Process Development, Engineering, and Validation teams to determine impact and corrective actions, while supporting audits and inspections as needed.