Specialist II, Inspection/Packaging

Company: Disability Solutions
Location: Bloomington
Posted on: October 12, 2024

Job Description:

Specialist II, Inspection and Packaging 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.--Catalent's facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services.The Drug Product Support department is responsible for supporting the Operations Team in the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. This includes Primary and Secondary Operations.---- Manufacturing cGMP production support activities include audit preparation, audit performance, documentation and metric tracking, documentation review, deviation identification and authoring, Corrective Actions, Change Management, and process improvements.--The Specialist II, Inspection and Packaging provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner.This is a fulltime, onsite role, working days; Monday - Friday.-- ----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

• Provide direct technical support for production processes and implementation of improvements
• Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP and document revision, review and approval
• Lead and participate in continuous improvement process changes
• Direct interaction with Client and Regulatory Auditors
• Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
• Works autonomously within established procedures and practices
• Perform Investigations and Root Cause Analysis in Global Trackwise quality system utilizing technical writing skills; Create and assist in implementation of Corrective and Preventative Actions (CAPAs)
• Other Tasks as AssignedThe Candidate
  • High School/GED with 3+ years' pharmaceutical and/or manufacturing experience required OR
  • Associate degree with 2 years' pharmaceutical and/or manufacturing experience required OR
  • Bachelor's degree in a manufacturing field of study with 1+ year pharmaceutical and/or manufacturing experience preferred
  • Audit and inspection experience preferredWhy You Should Join Catalent
    • Competitive medical benefits and 401K
    • 152 hours of PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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, Muncie , Specialist II, Inspection/Packaging, Other , Bloomington, Indiana