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Sr. Quality Assurance Specialist - Compliance

Company: Catalent
Location: Chelsea
Posted on: November 18, 2022

Job Description:

Position Summary:

Catalent Pharma Solutions is hiring a Senior QA Compliance Specialist who is responsible for both performing and supporting audits and driving continuous improvement initiatives for a GMP Manufacturing Facility.

This is a full time, salaried role, Day Shift Rotating Weekends

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 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 andcompliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

  • Performs Internal Audits across the various departments at the site, which includes conducting audits, tracking actions to closure, and writing reports.
  • Supports Supplier Quality Management.
  • Drives continuous improvement projects at the site, including collaboration with project sponsors and subject matter experts.
  • Supports Data Integrity/Part 11 initiatives driven by the global DIARP team.
  • Performs and/or collaborates on Risk Assessments as needed for new molecule onboarding and other projects.
  • Supports implementation of electronic Quality Systems at the site.
  • Supports FDA and EU medical device requirement assessments as needed for onboarding of new clients.
  • Hosts and/or supports client and Health Authority inspections.
  • Generates metrics and trend reports in support of management review & other QS initiatives, as necessary.
  • All other duties as assigned;

    The Candidate
    • Bachelor's degree preferred.
    • Minimum of five years of relevant work experience in the Biotechnology or Pharmaceutical industries or relevant comparable GMP background required.
    • Demonstrates working knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts (e.g. 21 CFR Parts 11, 210, 211, 820).
    • Experience in a GxP auditor role required.
    • Excellent oral and written communication skills.
    • Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

      Why you should join Catalent:
      • Defined career path and annual performance review and feedback process
      • Diverse, inclusive culture
      • 19 days of PTO + 8 paid holidays
      • Dynamic, fast-paced work environment
      • Positive working environment focusing on continually improving processes to remain innovative
      • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
      • Competitive salary with quarterly bonus potential
      • Community engagement and green initiatives
      • Generous 401K matchand Paid Time Off accrual
      • Medical, dental and vision benefits effective day one of employment
      • Tuition Reimbursement
      • On-site fitness center and wellness programs
      • GymPass program to promote overall physical wellness
      • Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

        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 . 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 , Sr. Quality Assurance Specialist - Compliance, Other , Chelsea, Massachusetts

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