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Catalent Pharma Solutions Quality Assurance Specialist II in Chelsea, Massachusetts

Job Title:

Quality Assurance Specialist II

Job Summary:

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 (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies

  • Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities

  • Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities

  • Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement

  • Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods

  • Other duties as assigned

The Candidate:

  • Bachelor’s degree in a scientific discipline is preferred, preferably in physical Science or Chemistry.

  • Minimum of 3-5 years of progressive experience in a GMP environment required.

  • Minimum of 1 year of Quality Assurance experience in support of GMP production required.

  • Working knowledge of GMPs and their application to pharmaceutical manufacturing required.

  • Previous exposure to investigations and product complaints preferred.

  • Must be able to interpret applicable standards and objectively make decisions with support of management.

  • Must be proficient in MS Office Suite.

  • Experience in the use of Material Requirements Planning (MRP) systems preferred.

Why you should join Catalent:

  • Competitive medical benefits and 401K

  • 19 days of PTO + 8 paid holidays

  • Collaborative teamwork environment

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 (https://careers.catalent.com/us/en) 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.

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