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Principal Analyst, QA

2 months ago

Bloomington, United States Catalent Inc Full time

Catalent Biologics is a fast-growing business within Catalent Pharma SolutionsWe're hiring for a Principal Analyst, QA to support the investigations team in Bloomington, IndianaCatalent 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 Principal 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 RolePulls 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 CandidateBachelor's degree in a STEM discipline.PhD or Certification (i.e. PE) preferred.8+ years of experience in pharmaceutical manufacturing, or related.4 years of GMP experience required or regulated industry.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.Catalent offers rewarding opportunities to further your career Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.Important Security Notice to U.S. Job Seekers:Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.