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Quality Assurance Specialist I

Company: Disability Solutions
Location: Chelsea
Posted on: May 3, 2024

Job Description:

We're hiring for a rotating night shift Quality Assurance Specialist I to provide QA support for cGMP manufacturing activities, at our facility in the Boston area!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.--The Quality Assurance Specialist I is responsible for supporting the QA oversight of a GMP manufacturing facility. This individual provides a real-time review of production activities. This is a full-time, salary position and is 100% site-based. The schedule is 6:00PM - 6:00AM and rotates from 48 hours of work in 4 days one week, to 36 hours of work in 3 days the following week (every other weekend will have work scheduled.) --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. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.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

  • Review of production activities, including area clearance, issuance, and review of batch records.
  • Support of Environmental Monitoring program, including water and other utilities sampling.
  • Disposition of controlled raw materials and work in progress materials.
  • Provide basic support during compliance inspections conducted by external sources (i.e. Health authorities).
  • Support GMP manufacturing shifts as needed, including participation in shift changes, and floor meetings with the operators.
  • Other duties as assigned.The Candidate,
    • Bachelor's degree in Life Sciences required.
    • Minimum of one year of progressive experience, in a GMP environment, required.
    • Minimum of one year of quality experience, in a GMP environment, required.
    • Experience working in a clean room environment preferred.Why you should join Catalent
      • Defined career path and annual performance review and feedback process.
      • Medical, dental and vision benefits effective on first day of employment.
      • Potential for career growth on an expanding team and organization.
      • 152 hours of paid time off annually plus 8 paid holidays.
      • Community engagement and green initiatives.
      • Competitive salary with bonus potential.
      • Tuition reimbursement program.
      • Diverse, inclusive culture.
      • Generous 401K match.---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 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, Chelsea , Quality Assurance Specialist I, Other , Chelsea, Massachusetts

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