Technical Investigation Writer

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 Technical Investigations Writer is responsible for performing investigation activities and writing deviation investigation reports supporting non-conforming (process and procedural deviation) events. Additionally, the Technical Investigations Writer will deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc. and create the associated CAPAs.

This is a full-time role position: Monday - Friday, 1st shift.

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

• Perform thorough investigations of Packaging and Supply Chain non-conforming events and customer complaints that could include review of cGMP documents and historical review of the quality management system.
• Perform investigations using structured root cause analysis tools (fishbone, 5 Why's, etc.) and partner with team members to determine "true" root cause.
• Conduct personnel interviews of those individuals involved with the event or customer complaint; Write concise and accurate investigation reports with the goal to be successful in the first pass through the quality review; Write interim reports and extensions for investigations that exceed 30 days.
• Adjust work hours across our 24x7 operation, when needed, to get all information required for accurate investigations.
• Generate trend analysis reports of historical investigation on an as needed basis.
• Partner with local and global teams on required process and system enhancements.
• Support client communications both written and oral with investigation follow ups.
• Other duties as assigned.

The Candidate

• Bachelor's Degree preferred, preferably in Science or Business (e.g., Chemistry, Pharmacy, Engineering, Operations)
• Minimum of 2+ years of CAPA, investigations, or manufacturing quality assurance experience preferred.
• Minimum of 5 years manufacturing/technical experience in a regulated GMP environment; pharmaceutical industry preferred.
• Must possess excellent investigative, documentation, technical writing, and proofreading skills.
• Individual may be required to site, stand, walk regularly; Occasionally lift 0-15 pounds
• Be accessible to manufacturing floor and office staff and to use required office equipment
• Specific vision requirements include reading written documents and frequent use of a computer monitor

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with possible bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.