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Quality Engineer, Deviation Writer - 3rd shift

Company: Catalent Pharma Solutions, Inc.
Location: Bloomington
Posted on: June 12, 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

Quality Engineer - Deviation Writer

Catalent is seeking a Quality Engineering Deviation Writer to join our growing team in Bloomington, Indiana.

This is a 3rd shift role working Sunday-Thursday 11pm-7:30am

A Quality Engineering (QE) deviation writer's primary duty is to ensure each deviation is thoroughly investigated and Quality impact assessed. A QE deviation writer must ensure timely completion of deviations within the Trackwise system to support our quality metrics, on-time batch release, and patient first. They will make recommendations for improvement or correction based on the Root Cause Analysis of the deviations.

The Role

* Supports the manufacturing of pharmaceutical products * Actively participates, suggests solutions to problems, drives to timelines * Conduct direct contact with clients and internal customers across the site * Ensure that documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities * Suggest Corrective and Preventative Actions (CAPAs), take ownership for their deviations and drive to meet deadlines * Perform Root Cause Analysis and Investigations in Trackwise * Clearly articulating issues identified during the investigations and utilizing your strong technical writing skills to document the issues

The Candidate

* Bachelor's Degree- Required * STEM discipline - Preferred * Master's degree or higher - Preferred * 2-5 years or more of experience in Quality Engineering or related discipline * 1-year GMP experience required or other regulated industry * Excellent communication skills * Self-motivated and action-oriented with the ability to work independently to problem solve and work cross functional across departments * 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 and Paid Time Off accrual * Medical, dental and vision benefits effective day one of employment * 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

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 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 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., Bloomington , Quality Engineer, Deviation Writer - 3rd shift, Other , Bloomington, Indiana

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