Vaccine Quality Complaints Investigator

Biopharma Careers; West Point (MS); On-site; USD 87,000 - 129,000; Full time

Benefits offered by this job

Medical insurance

Retirement benefits (401k)

Paid holidays

Vacation

Sick days

Job summary

Merck seeks a qualified investigator to support vaccine manufacturing complaint investigations and root-cause analysis. The candidate will lead CAPA development, product impact assessments, and BPDR/AEQIR drafting, while coordinating with cross-functional teams to drive continuous improvement.

The role requires GMP experience, a Life Sciences degree, and strong data analysis and documentation skills. Some process improvements and regulatory support may be involved.

Qualifications

• Bachelor’s degree in Life Sciences, Science or Engineering; other degrees considered with relevant GMP experience.
• Minimum 1 year post-degree GMP Manufacturing or related experience supporting manufacturing or regulatory functions.

Responsibilities

• Investigate customer complaints and perform second person review to determine root cause.
• Develop CAPAs and assess product impact and event scope for regulatory follow-up.
• Draft or review BPDR and AEQIRs as required.
• Support governance and cross-functional teams to drive continuous improvement.
• Collaborate with IPT areas to ensure robust processing and regulatory readiness.

Skills

Root cause analysis

CAPA Management

Data Analysis

Problem solving

Documentation Review

FDA Regulations

Quality inspections

Investigations

GMP Manufacturing

Cross-functional teamwork

Education

Bachelor’s degree in Life Sciences or related

Tools

BPDR/AEQIR Drafting tools

Job description

Merck seeks a qualified investigator to support vaccine manufacturing complaint investigations and root-cause analysis. The candidate will lead CAPA development, product impact assessments, and BPDR/AEQIR drafting, while coordinating with cross-functional teams to drive continuous improvement.

The role requires GMP experience, a Life Sciences degree, and strong data analysis and documentation skills. Some process improvements and regulatory support may be involved.