Merck & Co.

Specialist Quality Systems and Compliance

Merck & Co.

Durham, NC, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Merck & Co., where we strive to improve the health and well-being of people around the world. We are currently seeking a highly motivated and skilled individual to join our team as a Specialist Quality Systems and Compliance. As a member of our Quality Assurance department, you will play a crucial role in ensuring that our products are manufactured and distributed in compliance with all regulatory requirements. If you are passionate about maintaining high standards of quality and have a strong understanding of regulatory compliance, we encourage you to apply. Join us and make a meaningful impact on global health.

  1. Ensure compliance with all regulatory requirements for the manufacturing and distribution of our products.
  2. Develop and maintain quality systems and procedures to ensure consistent and high-quality product output.
  3. Conduct regular audits and reviews to identify potential areas of non-compliance and implement corrective actions.
  4. Collaborate with cross-functional teams to develop and implement quality improvement initiatives.
  5. Stay updated on industry regulations and guidelines and provide guidance and training to team members.
  6. Participate in the development and implementation of new products and processes, ensuring compliance with regulations.
  7. Investigate and resolve any quality-related issues or complaints in a timely and efficient manner.
  8. Maintain accurate and organized documentation of all quality system activities.
  9. Communicate and report on quality system performance and compliance to management.
  10. Participate in regulatory inspections and audits, providing necessary support and ensuring all necessary documentation is readily available.
  11. Identify opportunities for process improvement and drive continuous improvement efforts within the Quality Assurance department.
  12. Foster a culture of quality and compliance throughout the organization through training and awareness initiatives.
Where is this job?
This job is located at Durham, NC, USA
Job Qualifications
  • Bachelor's Degree In A Scientific Discipline, Such As Chemistry, Biology, Or Pharmacy.

  • Minimum Of 5 Years Of Experience In The Pharmaceutical Or Biotechnology Industry, With A Focus On Quality Systems And Compliance.

  • In-Depth Knowledge Of Fda Regulations And Guidelines, Including Cgmps, Glps, And Ich Guidelines.

  • Strong Understanding Of Quality Systems, Including Document Control, Change Control, And Deviation Management.

  • Experience With Conducting Internal And External Audits, And Working With Regulatory Authorities During Inspections.

Required Skills
  • Quality Assurance

  • Process Improvement

  • Data Analysis

  • Quality Control

  • Change control

  • Compliance Management

  • Risk assessment

  • Auditing skills

  • Documentation management

  • GMP compliance

  • Regulatory Knowledge

Soft Skills
  • Communication

  • Conflict Resolution

  • Customer Service

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Specialist Quality Systems and Compliance in Durham, NC, USA is $70,000 to $90,000 per year. This can vary depending on factors such as level of experience, education, and specific industry. Some companies may offer higher salaries for this role, while others may offer lower. It is important to research the specific company and job market to get a better understanding of the salary range for this position.

Additional Information
Merck & Co. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJune 23rd, 2025
Apply BeforeApril 11th, 2026
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About Merck & Co.

Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.

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