Quality Assurance Specialist: Adverse Events & GMP

1000 Merck Sharp & Dohme LLC; West Point (PA); Hybrid; USD 87,000 - 137,000; Full time

Benefits offered by this job

Benefits package including medical/ded

401(k) retirement plan

Paid holidays and vacation

Sick days and leave

Job summary

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, seeks a Quality Assurance Specialist (P2) to support Health Authority reporting, product complaints, adverse events, and sample coordination at the West Point site. The role requires GMP knowledge, collaboration across QA, Pharmacovigilance, Manufacturing and Regulatory Affairs.

Responsibilities include authoring investigation reports, handling complaint samples, maintaining records, and supporting regulatory inspections.

Qualifications

• Minimum 3 years in Pharmaceutical Quality or related field with GMP exposure.
• Experience with complaint handling, adverse event processes, or regulatory reporting.
• Interpersonal skills, collaboration, and proactive problem-solving.
• Ability to deliver results across multiple functional areas.

Responsibilities

• Author Adverse Event Quality Investigation Reports.
• Coordinate receipt, tracking, storage, shipment, testing, and disposition of complaint samples.
• Maintain complaint sample inventory and chain-of-custody records.
• Work with labs and investigation teams to meet timelines for testing.
• Author Health Authority responses and notifications.
• Review and update procedures, work instructions and training materials.

Skills

GMP knowledge

Quality Assurance

Regulatory compliance

Analytical thinking

Communication skills

Team collaboration

Education

Bachelor's degree in Life Sciences/Science/Engineering

Tools

QMS software

Job description

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, seeks a Quality Assurance Specialist (P2) to support Health Authority reporting, product complaints, adverse events, and sample coordination at the West Point site. The role requires GMP knowledge, collaboration across QA, Pharmacovigilance, Manufacturing and Regulatory Affairs.

Responsibilities include authoring investigation reports, handling complaint samples, maintaining records, and supporting regulatory inspections.