Facilities Compliance Specialist

4 days ago


Baltimore, Maryland, United States Catalent Inc Full time

About the Role:

The Facilities Compliance Specialist will report to the Manager of Facility Compliance. The role of the specialist is to provide support for facility quality. Provide regulatory guidance and GMP training to facilities and engineering team to maintain a high level of quality.

Key Responsibilities:

  • Ensure that all facility utilities preventive maintenance is performed in accordance with cGMP guidelines.
  • Generate SOP's, deviations, and change control as required for related Facilities systems.
  • Support compliance effort in facilities and engineering ensuring group operates in accordance to Catalent's cGMP quality system.
  • Maintain departmental industry compliance in support of GMP Manufacturing, Product Development administrative and laboratory activities.
  • Support client and regulatory audits, audit responses and follow up corrective actions when required.
  • Keep the leadership of Facilities and Engineering informed of abnormal or critical situations and seek advice on matters outside the specialist's knowledge or authority.
  • Provide training on GMP compliance.

Requirements:

  • BS degree in a technical field or equivalent experience.
  • 3 plus years of GXP quality system experience.
  • Experience in cross functional teams in a fast-paced environment.
  • Good working knowledge of facilities equipment and O&M requirements.
  • Understanding of GMP compliance for facilities.
  • Strong understanding of proper OSHA safety practices and procedures.

About Catalent:

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Why Work with Us:

  • Competitive medical benefits and 401K.
  • 152 hours PTO + 8 Paid Holidays.
  • Dynamic, fast-paced work environment.
  • Opportunity to work on Continuous Improvement Processes.

Catalent is an Equal Opportunity Employer



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