Stability Specialist II

Company: Catalent, Inc.
Location: Greenville
Posted on: May 23, 2023

Job Description:

Stability Specialist II

The Role

• Follow all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function
• Draft and revise new and existing stability frameworks to be routed for approval through appropriate channels
• Coordinate storage of samples in appropriate chamber conditions in accordance with internal procedures and signed frameworks
• Serve as Quality Control representative for internal and external clients, both commercial and non-commercial and, as required, CMOs
• Remove required number of samples as specified or requested, with appropriate documentation completed to assure chain of custody to and from stability group to laboratory group or client
• Demonstrate proficiency at using software to support stability job duties and functions
• Coordinate and perform annual physical inventory stored stability samples and reports results to stability supervisor
• Evaluate chamber capacity and excursions semiannually and reports information to stability supervisor
• Organize and supervise physical destruction of appropriate samples in accordance with appropriate procedures
• Perform quarterly logbook verifications and archival
• Train and mentor stability associates and works directly with study coordinators and department leads
• Other duties assigned
  
  The Candidate
  
  • Bachelor's degree in science with at least 6 years of relevant experience in the pharmaceutical industry
  • Associate degree in science with at least 7 years of relevant experience in the pharmaceutical industry
  • High school diploma with at least 8 years of relevant experience in the pharmaceutical industry
  • Potential handling of hazardous chemicals and other active chemical ingredients
  • Position requires the capacity to handle and manipulate objects using hands and arms
  • Position requires the ability to lift in excess of 30 lbs. unassisted
  • Requires the ability to effectively communicate using speech, vision and hearing
  • Requires the ability to stand for extended periods of time
    
    Catalent's standard leadership competencies that are used to interview and for Performance & Development
    
    • Leads with Integrity and Respect
    • Delivers Results
    • Demonstrates Business Acumen
    • Fosters Collaboration and Teamwork
    • Champions Change
    • Engages and Inspires
    • Coaches and Develops
      
      Position Benefits
      
      • Spearhead exciting and innovative projects
      • Fast-paced, dynamic environment
      • High visibility to members at all levels of the organization
      • 152 hours of PTO + 8 paid holidays
        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 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.
        
        California Job Seekers can find our California Job Applicant Notice HERE.

Keywords: Catalent, Inc., Greenville , Stability Specialist II, Other , Greenville, North Carolina