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Specialist, Quality Assurance - Kansas City, MO 64137

 

Catalent Pharma Solutions

 

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalentís 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

This role reports directly to the Supervisor, Quality Assurance.

Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.

The role

  • Responsible for the Quality support functions associated with the packaging of products for clinical and commercial batches
  • Performs batch record review, product release, and disposition
  • Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed
  • Assists in the execution of efficiency improvement projects with guidance
  • Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOP
  • Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines
  • Ensures gathering of data, investigations and deviations are timely and compliant
  • Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label control)
  • Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
  • Respond and interact with internal and external clients in a professional and timely manner
  • All other duties as assigned

The Candidate

  • Bachelorís or a Masterís degree in a scientific discipline or equivalent knowledge and experience.
  • Six Sigma or ASQ certification preferred.
  • Must be able to use existing procedures to solve routine and non-routine problems
  • Must be able to utilize all elements of the quality system to identify, classify and control the status of finished products produced
  • Be able to proactively address work issues at the individual and team level
  • Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form
  • Excellent written and verbal communications skills with internal and external customers, peers and managers

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually
  • Potential for career growth within an expanding team
  • Defined career path and annual performance review and feedback process

Catalentís standard leadership competencies

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

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 everyoneís 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.

 

 

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