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Veterans Preferred - Sr. QA Specialist

Company: Catalent
Location: Chelsea
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

Sr. QA Specialist

Position Summary:

The Senior Quality Assurance Specialist - Operations is responsible for supporting operations in a GMP Manufacturing Facility.

This position will be based at our Chelsea, MA facility. The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging.

Members of our Quality team are vital to ensuring our products, which include some of the latest life-saving medicines and the most well-known consumer health brands are reliably supplied so that the people can live better, healthier lives

The Role:

  • Oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
  • Oversight, review, and approval of Materials Management and Supply Chain activities
  • Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
  • Reporting on the state of control of the Controlled Environment and Clean Utilities for the Chelsea Manufacturing Site
  • Reporting on Quality Metrics for production related events
  • Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
  • Initiation, review, and approval of Discrepancies, including Deviations and Investigations.
  • Support of implementation of CAPA and review of CAPA effectiveness as determined through Discrepancies
  • Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
  • Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
  • Provide support during compliance inspections conducted by external sources (i.e. health authorities)
  • Active member of a self-directed work team with operations personnel to critically evaluate and continuously improve manufacturing control systems
  • Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators
  • Other duties may be assigned.

    The Candidate:
    • Bachelor's degree in a scientific discipline is required, preferably in physical Science or Chemistry.
    • Minimum of 5+ years of progressive experience in a GMP environment required.
    • Minimum of 5+ years of Quality Assurance experience in support of GMP production.
    • Must be proficient in MS Office Suite.
    • Experience in the use of Material Requirements Planning (MRP) systems preferred.
    • Excellent verbal and written communication skills.
    • Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
    • Ability to work both independently and in a collaborative team setting.
    • Ability to accept multiple tasks and adjust priorities, as assigned.
    • Physical requirements: combination of office work and time spent in the manufacturing facility.

      Why you should join Catalent:
      • Competitive medical benefits and 401K
      • 19 days of PTO + 8 paid holidays
      • Fast-paced, dynamic work environment
      • Site is rapidly growing and expanding
      • Conveniently located next to the train, parking available on-site

        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 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 . 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 for us to investigate with local authorities.

Keywords: Catalent, Chelsea , Veterans Preferred - Sr. QA Specialist, Other , Chelsea, Massachusetts

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