Veterans Preferred - Sr. Quality Assurance Specialist - Compliance

Company: Catalent
Location: Chelsea
Posted on: November 13, 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 - Compliance

Position Summary:

The Sr. QA Compliance Specialist is responsible for both performing and supporting audits and driving continuous improvement initiatives for a GMP Manufacturing Facility.

This position is based out of our Chelsea, MA site.

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.
• May participate in internal cross functional project driven sub-teams
• 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).
  • Must be proficient in MS Office Suite.
  • Knowledge of electronic quality systems such as Trackwise preferred.
  • Excellent oral and written communication skills.
  • Exhibits strong attention to detail.
  • Demonstrates risk-based thinking & application in day-to-to quality systems leadership decisions.
  • Ability to manage both day-to-day operations as well as project work in a fast paced environment.
  • Demonstrates emerging skills in influencing others within project teams regarding quality or compliance concerns.
    
    Why you should join Catalent:
    
    • Competitive medical benefits and 401K
    • 19 days of PTO + 8 Paid Holidays
    • Dynamic, fast-paced work 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 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 www.catalent.com/careers 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 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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