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Quality Specialist II - Client Services

Company: Catalent Pharma Solutions, Inc.
Location: Kansas City
Posted on: June 9, 2021

Job Description:

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

Catalent's Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.

Position Summary

The Quality Specialist II - Client Services is responsible for supporting the Client Audit Program for Catalent Kansas City.

The Role

  • Participate in pre-audit activities including scheduling and pre-audit communications with clients and internal stakeholders

  • Coordinate pre-audit meetings with internal stakeholders assigned to the project to gather relevant background information, as needed

  • Aid in ensuring all timelines related to the Client Audit program are met

  • Demonstrate a working knowledge of Kansas City site SOPs and other GMP documentation

  • Act as audit scribe and summarize audit close-out meetings for internal distribution

  • Assist in maintaining audit records within TrackWise

The Candidate

Education or Equivalent:

  • Bachelor's Degree in Chemistry, Biology or other related field required

Experience:

  • Two (2) or more years of Scientific or Quality Assurance experience.

Knowledge/Skills Requirements:

  • Communicates clearly with internal and external clients, both verbally and in writing.

  • Works well within and contributes to a team environment.

  • Works well under pressure.

  • Possesses an understanding of regulatory compliance relating to pharmaceutical and biotech industries.

  • Exhibits a proven ability to prioritize and manage multiple projects.

  • Customer related experience and excellent client facing skills.

Catalent's 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

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

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 www.catalent.com/careers to explore career opportunities.

Catalent 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.

Keywords: Catalent Pharma Solutions, Inc., Kansas City , Quality Specialist II - Client Services, Other , Kansas City, Kansas

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