Quality Systems Specialist Role at Glenmark Pharmaceuticals USA
Glenmark Pharmaceuticals Inc., USA is offering an exciting quality control job opportunity for a Quality Systems Specialist in Monroe, NC. This role focuses on managing and improving quality systems while ensuring CGMP compliance across pharmaceutical operations.
Job Details:
- Job Role: Quality Systems Specialist
- Location: Monroe, North Carolina, USA
- Industry: Pharmaceuticals
- Department: Quality Systems / Quality Assurance
- Employment Type: Full-time
- Experience Level: Minimum 3 years
About Glenmark Pharmaceuticals Inc:
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a global pharmaceutical company known for the discovery and development of New Chemical Entities (NCEs) and New Biological Entities (NBEs). The company has a strong presence in the US generics market and also supplies APIs to regulated and semi-regulated countries worldwide. Apply for more quality control jobs in the USA.
Educational Requirements for Quality Systems Specialist role:
Bachelor of Science (BS) or Bachelor of Arts (BA) in Science, or equivalent qualification
Key Responsibilities for Quality Systems Specialist role:Â
- Manage Quality Systems including Change Controls, Deviations, CAPA, QMR, and Risk Management
- Ensure investigations are logged, reviewed, and closed within regulatory timelines
- Perform root cause analysis and initiate corrective and preventive actions
- Track quality system metrics and generate trend analysis reports
- Ensure compliance with CGMPs and internal/external regulatory requirements
- Support Annual Product Review (APR) and Quality Management Review (QMR) activities
- Coordinate with cross-functional and global teams to improve quality processes
Skills Required for Quality Systems Specialist role:
- Strong knowledge of CGMP, FDA regulations, and ICH guidelines
- Excellent analytical, documentation, and decision-making skills
- Ability to manage multiple projects in a fast-paced environment
- Strong verbal and written communication skills
- Intermediate skills in Excel and/or Minitab
- Ability to work independently and collaboratively across teams
Benefits of the Role
- Opportunity to work with a global pharmaceutical leader
- Exposure to advanced quality systems and regulatory practices
- Career growth in quality assurance and quality control job roles
- Collaborative and professional work environment
- Hands-on involvement in site-wide quality improvements
