Job Description

Technical Investigations Writer

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID safe storage labels for your studies. Single panel and Peel-ID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia is hiring a Technical Investigations Writer. The Technical Investigations Writer is responsible for performing robust investigation/fact finding to identify root cause(s) and contributing factor(s) for non-conforming events. The investigator will employ strong technical writing skills to document findings with clarity and accuracy within Operations/Quality approved investigation reports. Additionally, the Technical Investigations Writer will deploy effective root cause analysis tools, such as 5-why analysis, fishbone diagrams, etc. and collaborate with area management to identify associated CAPAs.

This is a full-time role position: Monday-Friday -Day shift. Onsite

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 non-conforming events related to packaging, warehousing, supply chain, and other Catalent PHL processes as needed. Investigations may include review of cGMP documents, procedures, employee interviews 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
• Schedule/lead RCA meetings and collaborations with cross functional areas to ensure robust understanding of root cause
• Participate in defining SMART (Specific, Measureable, Attainable, Realistic, Timebound) CAPA after investigation process is complete
• Conduct personnel interviews of those individuals involved with the event
• Write concise and accurate event investigation reports employing strong technical writing principles for precision and clarity
• Adjust work hours across our 24x7 operation, when needed, to gather all information required for accurate investigations
• All other duties as assigned

The Candidate

• Requires a High School Diploma or GED plus a minimum of four years of experience in relevant industry; OR a Bachelors Degree
• Strongly prefer a minimum of three years of experience in GMP/Pharmaceutical industry
• Excellent investigative, documentation, technical writing, and proofreading skills are favourable
• Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 15 pounds

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 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
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• WellHub- 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.

Personal initiative. Dynamic pace. Meaningful work.

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