Veterans Preferred - Documentation Specialist, Technical Services

Company: Catalent
Location: Saint Petersburg
Posted on: November 17, 2021

Job Description:

Military Veterans are Encouraged to Apply. Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

Documentation Specialist, Technical Services

St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

Technical Services is responsible for providing commercial technical support over the lifecycle of all products, driving continuous improvement throughout the manufacturing environment, facilitating commercial technology transfers and ensuring Launch Excellence during the new product introduction process.

This position is responsible for reviewing, writing, implementing and maintaining documentation such as batch records, protocols, IPC recipes, technical assessments and electronic weigh and dispense system per applicable SOPs. To accomplish these responsibilities requires experience and understanding of document change control procedures, computer systems, and manufacturing process knowledge within a cGMP environment.

If you share a passion for patient care in the growing world of pharmaceutical manufacturing and would like to be part of a global drug development and delivery leader, then this might be for you!

The Role

• Review, write, or revise master batch records to support new products via technical transfers and initiate improvements/updates for existing commercial products.
  
• Review, write or revise Technical Services protocols to support technical transfers, qualification of alternate suppliers, manufacturing gap assessments or other protocol-driven tasks for the Technical Services department.
  
• Review, write or revise IPC recipes for new products or existing commercial products. Review, write or revise electronic weigh and dispense system recipes (POMS). Review, write, or revise technical assessments with input from department SMEs. Review, write, or revise SOPs with input from the change initiators. Review, write, or revise Change Control in accordance with Catalent's SOPs.
  
• Addend master batch records prior to execution in support of Technical Services protocols and other associated functions.
  
• Maintain all Technical Services documents, electronically or physically, for immediate, rapid retrieval.
  
• Electronically scan completed Technical Services documentation, as needed.
  
• Perform training on documents with cross-functional teams, as needed
  
• Participates in the creation and review of current and proposed procedures. Ensures compliance with cGMPs and departmental procedures.
  
• Proposes and assist in the implementation of quality improvements to document control systems.
  
• Other duties as assigned.
  
  
  The Candidate
  
  • Requires a Bachelor's degree in a relevant business discipline or equivalent experience, or applicable combination. A technical background and/or degree in a science (including computer science) is preferred.
    
  • A minimum of 3 to 5 years' experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), at least 1-2 years in the pharmaceutical industry is preferred.
    
  • Understanding of cGMPs as they apply to documentation systems.
    
  • High-level understanding of manufacturing processes.
    
  • A minimum of 1-2 years of experience authoring written and electronic batch record recipes is preferred.
    
    Why you should join Catalent
    
    • Cross functional exposure to other areas of Operations
      
    • Medical, Dental, Vision and 401K are all offered from day one of employment
      
    • 152 hours of paid time off annually + 8 paid Holidays
      
      
      
      We will identify candidates based on the following Catalent Competencies:
      
      • Leads with Integrity and Respect
        
      • Delivers Results
        
      • Demonstrates Business Acumen
        
      • Fosters Collaboration and Teamwork
        
      • Champions Change
        
      • Engages and Inspires
        
      • Coaches and Develops
        
        
        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 customersand 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 www.catalent.com/careers to explore career opportunities.
        
        C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.

Keywords: Catalent, St. Petersburg , Veterans Preferred - Documentation Specialist, Technical Services, IT / Software / Systems , Saint Petersburg, Florida