Quality Assurance Representative

Company: Catalent
Location: Bloomington
Posted on: February 11, 2019

Job Description:

Job DescriptionPosition Overview:-- Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures, packages and distributes pharmaceutical and other products for customers in nearly 100 countries. https://www.youtube.com/watch?time_continue=1&v=65rz3LwTPX8Quality Assurance RepresentativePosition SummaryCatalent is hiring a Quality Assurance Representative to join our growing Quality team in Bloomington, IN.-- Catalent---s facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services.The Quality Assurance Representative---s primary duty is to support the quality function by overseeing GMP activities, documentation and reports.--Responsibilities include participating in and supporting internal, client, regulatory and/or vendor audits to ensure internal and external operations that impact SISPQ are in compliance with regulations and procedures/policies, maintaining quality systems, processes, and facilities by observing manufacturing operations and reviewing documentation for-- compliance and executing assigned quality tasks (e.g., pre-approving instructions, reviewing documentation of executed instructions, --reporting metrics, document drafting), providing review and approval of change request (e.g., Trackwise change controls and EDMS document change requests), approving item masters, product specifications and materials for usage in manufacturing, providing direction for and reviewing and approving deviations, corrective and preventive actions, vendor assessments, risk assessments, and nonconforming material reports, and reviewing resolution and effectiveness of corrective actions and audit responses.--In concert with Catalent---s Patient First philosophy, the Quality Assurance Representative is key to ensuring that quality and compliance are maintained throughout all processes at Catalent.The Role

• Regularly applies theories and principles for one's technical discipline
• Works independently to solve problems of moderate scope
• Actively participates, suggests solutions to problemsThe Candidate
  • Bachelor---s degree
  • 2-5 years of experience
  • 1 year GMP experience requiredCatalent---s standard leadership competencies that are used to interview and for Performance & Development:
    • Leads with Integrity and Respect
    • Delivers Results
    • Demonstrates Business Acumen
    • Fosters Collaboration and Teamwork
    • Champions Change
    • Engages and Inspires
    • Coaches and DevelopsPosition Benefits
      • Potential for career growth within an expanding team
      • Diverse, inclusive culture
      • 152 hours of Paid Time Off per year
      • Medical, dental, and vision insurance, as well as company matching 401k
      • On-site fitness center and wellness programsCatalent 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. More products. Better treatments. Reliably supplied. ---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, Bloomington , Quality Assurance Representative, Other , Bloomington, Indiana

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