Quality Assurance Specialist - GMP & Packaging

MSD Malaysia

Wilson (NC)

On-site

USD 78,000 - 89,000

Full time

4 days ago
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Benefits offered by this job

Medical
Dental
Vision
401(k) retirement
Paid holidays
Vacation
Sick days

Job summary

Merck & Co., Inc. is seeking a Quality Assurance professional to support shop floor activities and packaging QA at Wilson operations. The role focuses on defect resolution, material control, batch record review, and continuous improvement in a GMP environment.

Experience in pharmaceutical operations, strong documentation skills, and ability to work on 3rd shift are required. This position offers competitive salary and benefits.

Qualifications

  • Education and experience requirements include High School Diploma with 3+ years in manufacturing or technical roles, or a Bachelor’s degree in science preferred.
  • Knowledge of pharmaceutical operations systems, GMP, NDA and related regulations is required.
  • 3rd shift availability (Sunday-Thursday 11:30PM - 8:00AM) may be required.

Responsibilities

  • Provide direct shop floor support (counts, material tagging, production event support).
  • Provide quality oversight of the packaging process and plant site.
  • Evaluate defect resolution and control of material throughout the plant.
  • Apply material control and ensure compliance with GMPs and company Quality policies.
  • Perform batch record review activities of intermediate/finished product.
  • Maintain 5S organization and identify improvement opportunities.
  • Trend compliance performance indicators and drive improvement.
  • Participate in implementation of new programs/regulations at the site.
  • Lead or participate in root cause analysis and corrective actions as needed.
  • Support safety initiatives and promote team effectiveness.

Skills

Adaptability
Analytical Problem Solving
Aseptic Manufacturing
Auditing
Cleaning Equipment
Customer Communications
Data Analysis
Engineering Physics
Environmental Monitoring
Equipment Maintenance
GMP Compliance
Inventory Accuracy
Inventory Control Management
Inventory Maintenance
Inventory Management
Inventory Management System
Laboratory Instrumentation
Laboratory Operations
Laboratory Testing
Manufacturing
Problem Analysis
Product Inspections
Product Specifications
Product Testing

Education

High School Diploma
Bachelor’s degree preferred

Job description

Merck & Co., Inc. is seeking a Quality Assurance professional to support shop floor activities and packaging QA at Wilson operations. The role focuses on defect resolution, material control, batch record review, and continuous improvement in a GMP environment.

Experience in pharmaceutical operations, strong documentation skills, and ability to work on 3rd shift are required. This position offers competitive salary and benefits.

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