Veterans Preferred – QC Investigations

Military Veterans are Encouraged to Apply.

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 The QC Investigations primary role is to provide Quality Control Technical and Compliance Data review and investigational support to the Quality Control department.

Catalent Pharma Solutions in Bloomington, Indianais a state of the art,GMP manufacturing facility,providing one millionsq/ft of adrug 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.

This position works days; Monday
– Friday Catalent is committed to a Patient First culture through excellence in quality andcompliance, and to the safety of every patient, consumer and Catalent employee.

NOTE: Upon hire the technical title for this role will be QC Representative.

The Role Serves as the primary investigator for deviations and laboratory investigations within QC Conduct Root Cause Analysis
– demonstrating critical thinking and attention to detail utilizing a wide variety of tools such as FMEA and fishbone Interact with clients on status of investigations and implement Corrective Actions Ensures compliance through conducting technical and compliance reviews (second person verification) of QC raw data from in-process, final product, stability, method qualification and EM/Micro test results Communicate and resolve corrections with a wide range of operators across several shifts and departments The Candidate Bachelor’s degree preferred 2-5 years of similar experience to include laboratory experience 1 year GMP experience required or other regulated industry Previous technical writing or laboratory investigation experience preferred Must be able to read and understand English-written job instructions and safety requirements 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’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 Bloomington site is proud to offer the following: 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 matchand Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement On-site fitness center and wellness programs 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 customersand 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 DisabilityAccommodationscatalent.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.