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Catalent Pharma Solutions Quality Assurance Representative - Batch Record - 3rd Shift, Sunday - Thursday, 7pm – 2.30am. in Bloomington, Indiana

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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Position Summary:

A Quality Assurance (QA) 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

This is a full time position. It is a salary position.

The shift is Sunday - Thursday, 7pm – 2.30am.

Catalent Pharma Solutions in Bloomington, Indiana is a state of the art, GMP manufacturing facility, providing one million sq/ft of a drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

  • Requires in-depth knowledge and experience;

  • Uses best practices and knowledge of internal or external business issues to improve products or services;

  • Solves complex problems; takes a new perspective using existing solutions;

  • Works independently and receives minimal guidance;

  • Acts as a resource for colleagues with less experience;

  • Competent at risk mitigation for function;

    The Candidate:

  • Bachelor’s degree preferred – scientific background;

  • 2-5 years of relevant experience with Bachelor’s degree;

  • 5+ years of experience or demonstrated excellence in role with justification;

  • 1 year GxP experience or other regulated industry;

  • Must be able to read and understand English-written job instructions and safety; requirements.

Catalent Benefits:

  • Defined career path and annual performance review and feedback process

  • Diverse, inclusive culture

  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives;

  • Competitive salary with quarterly bonus potential

  • Community engagement and green initiatives

  • Generous 401K match

  • Tuition Reimbursement

  • On-site fitness center and wellness programs

    Catalent’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 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 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.

Catalent = Catalyst + Talent

Your 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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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