Senior Analyst, QA

We're hiring for multiple Senior Analyst, QA roles to support the investigations team in Bloomington, Indiana!

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. 

Catalent Biologics in Bloomington, Indiana is a state-of-the art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

A Senior Analyst, QA is responsible for investigating and reporting on major and critical deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. This person will interact with multiple departments to understand a problem, identify root cause(s), and assist in identifying appropriate corrective and/or preventive actions (CAPA) to prevent reoccurrence. The Investigator assists Operations and Quality Assurance teams to determine the disposition of non-conforming in-process product and determines if a field alert or recall is required for product that has been released. This is a full-time, salaried position and is 100% site based. The schedule is Monday – Friday, 1st shift.

The Role

• Pulls together and leads, as appropriate, multi-function teams to trouble shoot, identify root cause(s) and inform on the Corrective and Preventative measure for all deviations.

• Reviews the initial triage and RPN score of each assigned deviation investigation to ensure it aligns with the company standard and is appropriately classified.

• Works with the Quality unit to address any discrepancies or concerns with the classification.

• Required, as appropriate, to seek out and identify, on location, the processes, equipment and any other areas where a problem related event occurred to view and understand first-hand what happened or could happen.

• Works with the team to clearly identify and communicate the problem statement that can focus the investigation.

• Effectively work with a team of SME’s to quickly identify the potential scope of an issue and as required escalate to Leadership to ensure proper actions with customers and regulatory agencies, as required, are properly made and managed.

• Conduct interviews in a logical and information seeking way to help uncover issues and understand the.

• Identifies first, all possible corrective and preventative measures through the use of engineering solutions and only moves to administrative controls after the cost/benefit and compliance risk are understood and addressed.

• Completes all investigation information into a comprehensive deviation report in a manner that clearly defines the problem, the facts and evidence (including circumstantial) that drives a strong root cause conclusion, where possible and is linked to clear and actionable CAPA.

• Other duties as assigned.

The Candidate

• Bachelor’s degree required.

• Bachelor's degree in a STEM discipline preferred.

• Master’s degree or higher preferred.

• Minimum of 5 years pharmaceutical manufacturing experience, or related.

• 2 years of GMP experience, or similar regulated industry, required.

• Prior experience with cGMP deviation writing, highly preferred.

Why you should join Catalent:

• 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.