GMP Quality Complaints Investigator

MSD Malaysia; West Point (PA); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Benefits

Paid Holidays

Job summary

Merck is seeking a detail-oriented investigator to support the complaint program and regulatory obligations. You will lead root-cause analyses, develop CAPAs, and draft Health Authority notifications when required.

You'll collaborate with cross-functional teams to ensure robust processing, quality audits, and continuous improvement. A GMP background and strong documentation practices are essential for success in this role.

Qualifications

• Required Bachelor’s degree in Life Sciences, Science, or Engineering or equivalent.
• Minimum 1 year post-degree experience in GMP Manufacturing or related field.

Responsibilities

• Investigate customer complaints and determine root cause; define CAPAs and action plans.
• Review product impact, event scope, and laboratory data for quality decisions.
• Draft and review notifications to Health Authorities as needed.
• Support complaints governance meetings and cross-functional teams.
• Collaborate across IPT areas to drive robust processing and continuous improvement.
• Maintain retention samples and evaluate batch records as applicable.
• Draft BPDR and AEQIRs and ensure compliance with regulatory standards.
• Support site safety, environmental, and compliance objectives.
• Champion the use of Production System tools in problem solving.

Skills

Aseptic Manufacturing

CAPA Management

cGMP Compliance

Data Analysis

Project Management

FDA Regulations

Documentation Review

Quality Reporting

Quality Operations

Process Improvements

Decision Making

Interpersonal Relationships

Investigations

Education

Bachelor’s degree

Life Sciences, Science, or Engineering degree preferred

Tools

BPDR systems

Quality systems software

Job description

Merck is seeking a detail-oriented investigator to support the complaint program and regulatory obligations. You will lead root-cause analyses, develop CAPAs, and draft Health Authority notifications when required.

You'll collaborate with cross-functional teams to ensure robust processing, quality audits, and continuous improvement. A GMP background and strong documentation practices are essential for success in this role.