Senior Scientist QC Compliance Specialist

3 weeks ago

Harmans, Maryland, United States Catalent Inc Full time
Job Title: Senior Scientist QC Compliance

The **Sr. QC Scientist - Compliance** role is critical to our patients' safety and well-being. This position is responsible for supporting compliance in the Quality Control Laboratory, including authoring, management, and/or tracking of investigations/events/deviations, Corrective Action / Preventive Action (CAPA), change control, and other Quality records. This role will facilitate the compiling, trending, completing, and reporting of key quality metrics for management accountability and other quality control functions, as needed. Continuously monitor systems, logbook management, and testing procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase-appropriate GMP manufacture of biological products.

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.

Key Responsibilities:

  • Complete Quality Records investigations that meet both Industry and Catalent expectations
  • Initiate and complete the write-up and closure of Investigations, Deviations, and Change Controls
  • Leads or manages investigations, including root cause analysis, and assesses product impact using input from various departments
  • Develops, executes, and oversees CAPAs, as appropriate
  • Provides technical leadership to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective
  • Assists with the generation and/or revision of GMP documentation, such as standard operating procedures
  • Participates in site quality and process improvement initiatives, represents the QC Department on site project teams, and participates in QC internal audits as applicable

Requirements:

  • Bachelor's degree in a science or engineering field, preferred
  • 4+ years of demonstrated technical competency in a biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory or equivalent experience in a GMP compliance environment (e.g., Quality Assurance, Production, Technical Services, or related field)
  • Experience in Quality/Compliance function, in completion of deviation investigations and remediation or significant participation with investigations/deviations/events/etc., within a laboratory setting
  • Experience with the analytical and/or bioanalytical testing process and/or EM Microbiology laboratory settings, preferred
  • Ability to perform investigation-related interviews and familiarity with root cause analysis
  • Previous experience authoring and/or revising technical documents

Why Catalent?

  • 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 a global drug development and delivery leader, and we're committed to advancing new medicines from early development to clinical trials and to the market. We produce more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

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