Senior Analyst, QA

Catalent - Bloomington, IN

Full-time - Senior

Bloomington, IN

10,001+ employees

Chemical Manufacturing

About the position

As a Senior Analyst, QA at Catalent, you will play a crucial role in supporting the investigations team at our state-of-the-art GMP manufacturing facility in Bloomington, Indiana. This facility is dedicated to the development and manufacturing of new treatments for patients worldwide, and your contributions will be essential in maintaining our commitment to quality and compliance. In this full-time, salaried position, you will be responsible for investigating and reporting on major and critical deviations in the manufacturing process, addressing customer complaints regarding finished products, and resolving other manufacturing issues as assigned. Your work will directly impact our mission to help people live better, healthier lives. In this role, you will lead multi-functional teams to troubleshoot and identify root causes of deviations, ensuring that all investigations align with company standards. You will review the initial triage and Risk Priority Number (RPN) score of each assigned deviation investigation, working closely with the Quality unit to address any discrepancies. Your responsibilities will also include seeking out and identifying processes, equipment, and areas where problems have occurred, allowing you to gain firsthand insight into the issues at hand. You will collaborate with Subject Matter Experts (SMEs) to clearly define problem statements that focus investigations effectively. Your investigative work will involve conducting logical and information-seeking interviews to uncover issues and understand the underlying causes. You will identify potential corrective and preventative measures, prioritizing engineering solutions before considering administrative controls. Completing comprehensive deviation reports will be a key part of your role, ensuring that each report clearly defines the problem, presents the facts and evidence, and links to actionable Corrective and Preventative Actions (CAPA). Your expertise will be vital in determining the disposition of non-conforming in-process products and assessing whether field alerts or recalls are necessary for released products.

Responsibilities

• Investigate and report on major and critical deviations to the manufacturing process.
• Address customer complaints regarding finished products and other manufacturing problems as assigned.
• Lead multi-functional teams to troubleshoot and identify root causes of deviations.
• Review initial triage and RPN score of each assigned deviation investigation to ensure alignment with company standards.
• Work with the Quality unit to address discrepancies or concerns with classification of deviations.
• Identify processes, equipment, and areas where problems occurred to gain firsthand understanding.
• Clearly identify and communicate problem statements to focus investigations effectively.
• Conduct logical and information-seeking interviews to uncover issues.
• Identify potential corrective and preventative measures, prioritizing engineering solutions.
• Complete comprehensive deviation reports that define problems and link to actionable CAPA.

Requirements

• Bachelor's degree in a STEM discipline.
• Master's degree or higher preferred.
• 5-8 years of pharmaceutical manufacturing experience or related field.
• 2 years of GMP experience required or experience in a regulated industry.

Nice-to-haves

• Experience in a leadership role within quality assurance or investigations.
• Familiarity with regulatory requirements in the pharmaceutical industry.
• Strong analytical and problem-solving skills.

Benefits

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