Investigator

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.

The Investigator role 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 fulltime role working Monday – Friday; 8AM – 5PM

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.

The Role

• Independently investigate biopharmaceutical operations and facility problems, identifying any deviations from standards. This includes clearly defining problems, collecting, and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.
• Review supporting documentation including batch documentation, ancillary documentation, test results /CoAs, Product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents in support of the investigation.
• Collaborate with process SMEs, technical, and production personnel to understand events and occurrences. Facilitate meetings with various groups to discuss processes, participate in Kaizen events, and apply formal RCA tools to develop an investigational path for deviations. Present regular updates to the Site Leadership Team.
• Independently write complex technical reports, describing investigation results and complete according to standard reporting and completion timelines for on time closure. Manage multiple priorities and deadlines independently or as part of a team to meet critical deadlines and company and departmental metrics. Conduct GMP, GDP, SOP, and awareness training as needed for deviation resolution.

The Candidate

• Bachelor’s degree in a STEM discipline
• Master’s degree or higher preferred
• 2-5 years of experience in a similar QA role requiring critical thinking skills
• 1 year of GMP experience required or other regulated industry
• Must be able to read and understand English-written job instructions and safety requirements

Why You Should Join Catalent

• Competitive medical benefits and 401K
• 19 days of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.