Quality Systems Specialist

4 weeks ago


Bloomington, Indiana, United States Glenmark Pharmaceuticals Inc., USA Full time
Job Title: Quality Systems Specialist

Glenmark Pharmaceuticals Inc., USA is a leading player in the discovery of new molecules, with a strong presence in the pharmaceutical industry. We are seeking a highly skilled Quality Systems Specialist to join our team.

Job Summary:

The Quality Systems Specialist will be responsible for managing the elements of the Quality Systems, including Change Controls, Quality Events, Deviations, Corrective and Preventative actions, QMR, and Risk Management. This individual will work closely with cross-functional teams at the site and abroad, providing support in resource planning, allocation, and managing within approved budgets.

Key Responsibilities:
  • Investigate and resolve quality issues in a timely manner.
  • Coordinate with cross-functional teams for testing of reserve or retain samples for investigation purposes.
  • Conduct root cause analysis to facilitate and initiate corrective and preventative actions.
  • Track quality system metrics and create detailed trend analysis reports.
  • Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.
  • Coordinate evaluation of implementation for Global Policies and Procedures.
  • Support implementation of projects that improve site Quality and/or efficiency.
Requirements:
  • Bachelor of Science (BS) / Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent.
  • Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.
  • Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry.
  • Proactive, results-oriented with a strong attention to detail and strong time management skills.
  • Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment.
Preferred Qualifications:
  • Quality or lean/Six Sigma certifications.
  • Intermediate Excel and/or Minitab skills.

Glenmark Pharmaceuticals Inc., USA is an equal opportunity employer. We welcome applications from diverse candidates. Please submit your application to start your career with us.



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