Principal Analyst, QA

Catalent - Bloomington, IN

Full-time - Senior

Bloomington, IN

501-1,000 employees

Chemical Manufacturing

About the position

Catalent Biologics is seeking a Principal Analyst, QA to join our investigations team in Bloomington, Indiana. This role is pivotal in supporting our commitment to quality and compliance within our state-of-the-art GMP manufacturing facility. As a Principal Analyst, you will be responsible for investigating and reporting on major and critical deviations in the manufacturing process, addressing customer complaints regarding finished products, and tackling other manufacturing issues as assigned. Your expertise will be essential in interacting with multiple departments to understand problems, identify root causes, and assist in developing appropriate corrective and preventive actions (CAPA) to prevent recurrence. In this full-time, salaried position, you will lead multi-functional teams to troubleshoot and identify root causes of deviations. You will review the initial triage and RPN score of each assigned deviation investigation to ensure alignment with company standards and appropriate classification. Your role will require you to seek out and identify processes, equipment, and areas where problems occurred, allowing you to gain firsthand insight into the issues at hand. You will work collaboratively with subject matter experts (SMEs) to clearly define and communicate problem statements that focus investigations effectively. Additionally, you will conduct interviews in a logical and information-seeking manner to uncover issues and understand the context of deviations. Your analytical skills will be crucial in identifying potential corrective and preventive measures, prioritizing engineering solutions before considering administrative controls. You will compile comprehensive deviation reports that clearly define problems, present facts and evidence, and link findings to actionable CAPA. This position is 100% site-based, with a Monday to Friday schedule on the first shift.

Responsibilities

• Lead multi-functional teams to troubleshoot and identify root causes of deviations.
• Review initial triage and RPN score of assigned deviation investigations to ensure alignment with company standards.
• Work with the Quality unit to address discrepancies or concerns with classification.
• Identify processes, equipment, and areas where problems occurred to gain firsthand insight.
• Clearly identify and communicate problem statements to focus investigations.
• Conduct interviews to uncover issues and understand the context of deviations.
• Identify potential corrective and preventive measures, prioritizing engineering solutions.
• Complete comprehensive deviation reports that define problems and link findings to actionable CAPA.
• Assist Operations and Quality Assurance teams in determining the disposition of non-conforming in-process products.
• Determine if a field alert or recall is required for released products.

Requirements

• Bachelor's degree in a STEM discipline.
• PhD or Certification (i.e. PE) preferred.
• 8+ years of experience in pharmaceutical manufacturing or related fields.
• 4 years of GMP experience required or experience in a regulated industry.

Nice-to-haves

• Experience with regulatory agencies and customer interactions.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.

Benefits

• Defined career path and annual performance review and feedback process.
• Medical, dental and vision benefits effective on 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.