Senior Analyst, QA

Catalent - Bloomington, IN

Full-time - Senior

Bloomington, IN

10,001+ employees

Chemical Manufacturing

About the position

The Senior Analyst, QA role at Catalent is focused on investigating and reporting major deviations in the manufacturing process, addressing customer complaints, and resolving other manufacturing issues. This position is integral to ensuring compliance and quality in a state-of-the-art GMP manufacturing facility, contributing to the overall mission of helping patients live healthier lives. The role involves collaboration with various departments to identify root causes and implement corrective and preventive actions (CAPA).

Responsibilities

• Investigate and report on major and critical deviations to the manufacturing process.
• Interact with multiple departments to understand problems and identify root causes.
• Assist in determining the disposition of non-conforming in-process products.
• Lead multi-function teams to troubleshoot and identify corrective actions for deviations.
• Review initial triage and RPN scores of assigned deviation investigations.
• Conduct on-site investigations to understand processes and equipment related to issues.
• Communicate problem statements clearly to focus investigations.
• Identify and escalate issues to leadership as necessary.
• Conduct logical interviews to uncover issues and understand problems.
• Complete comprehensive deviation reports linking problems to actionable CAPA.

Requirements

• Bachelor's degree required; STEM discipline preferred.
• Master's degree or higher preferred.
• Minimum of 5 years pharmaceutical manufacturing experience or related field.
• 2 years of GMP experience or similar regulated industry required.
• Prior experience with cGMP deviation writing highly preferred.

Nice-to-haves

• Experience in a high-growth, public company environment.
• Familiarity with regulatory compliance in the pharmaceutical industry.

Benefits

• Defined career path and annual performance review process.
• Medical, dental, and vision benefits effective on the first day of employment.
• 152 hours of paid time off annually plus 8 paid holidays.
• Tuition reimbursement program.
• Generous 401K match.
• Competitive salary with bonus potential.
• Community engagement and green initiatives.
• Diverse, inclusive culture.