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Senior QA Representative - Audit Host

Company: Catalent Pharma Solutions
Location: Bloomington
Posted on: January 14, 2020

Job Description:

Job DescriptionPosition Overview: Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalents 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 hereA Senior Quality Assurance (QA) Representative - Audit Hosts primary duty is to act as a host for clients and regulatory representatives who conduct audits on location at Catalent.In concert with Catalents Patient First philosophy, the Senior Quality Assurance Representative is key to ensuring that quality and compliance are maintained throughout all processes at Catalent.The Role

  • Prepare for, greet and act as a liaison for auditor visiting onsite
  • 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 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 (CAPAs), risk assessments, and nonconforming material reports
  • Reviewing resolution and effectiveness of corrective actions and audit responses
  • Write and revise investigationsThe Candidate
    • Bachelors degree preferred
    • 5-8 years of experience in Technical Writing and/or QC Laboratory
    • 8+ years of experience or demonstrated excellence in role with justification
    • Minimum of 2 years GMP experience or other regulated industry
    • Excellent communication and interpersonal skills
    • Auditing experience in a Pharma environment highly desired
    • Strong tech writing skillsCatalents 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 DevelopsCatalents 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 or lyophilized vials and prefilled syringes, along with an array of support services. The Bloomington site is proud to offer the following:
        • Diverse, inclusive culture
        • Competitive salary with quarterly bonus potential
        • Educational assistance/reimbursement
        • On-site fitness center and wellness programs
        • Excellent on-site cafeteria
        • Robust Employee Referral ProgramCatalent 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. 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.Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.Catalent = Catalyst + TalentYour talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!personal initiative. dynamic pace. meaningful work.Catalent is the perfect place to grow your career if
          • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
          • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year more than any branded drug maker in the world!
          • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
          • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
          • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
          • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here. 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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Keywords: Catalent Pharma Solutions, Bloomington , Senior QA Representative - Audit Host, Accounting, Auditing , Bloomington, Indiana

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