Technical Investigation Writer

Company: Disability Solutions
Location: Philadelphia
Posted on: February 2, 2025

Job Description:

Technical Investigation WriterPosition Summary: Catalent is a global, high-growth, private 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.----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, PA is hiring a Technical Investigations Writer. The Technical Investigations Writer is responsible for performing investigation activities and writing deviation and customer complaint 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, salaried role on-site. This is on 1st shift. The core hours are Monday - Friday, 9am-3pm.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 manufacturing/packaging non-conforming events 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
• Participate in defining "right" CAPA after investigation process is complete
• Conduct personnel interviews of those individuals involved with the event
• Write concise and accurate event 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, in order to get all information required for accurate investigations
• All other duties as assignedThe Candidate:
  • High School Diploma or General Education Diploma with at least eight years' experience in pharmaceutical GMP environment OR Bachelor's Degree preferably in Science or Business (e.g., Chemistry, Pharmacy, Engineering, Operations) is required
  • At least two+ years of CAPA, investigations, or manufacturing quality assurance experience is preferred
  • At least five years manufacturing/technical experience in a regulated GMP environment; pharmaceutical industry is preferred
  • Must possess excellent investigative, documentation, technical writing, and proofreading skills
  • Individual will be required to stand and/or sit for long periods of time, occasionally lift 0-15 poundsWhy 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--
    • Company match on donations to organizations
    • Medical, dental and vision benefits effective day one of employment--
    • 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 categoriesCatalent 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.Visit 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 . 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 .

Keywords: Disability Solutions, East Orange , Technical Investigation Writer, IT / Software / Systems , Philadelphia, New Jersey