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Compliance Coordinator

Location
Woodstock, IL

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nnJob DescriptionnJob DescriptionJob Title Compliance CoordinatorrnPosition Summary The position is responsible for internal data management related to the quality and/or regulatory disciplines at the Woodstock site.The Quality Assurance Methods Generalist reports to the Quality Assurance Supervisor. This position directly supports the Catalent Patient First philosophy by improving process through initiation and response to customer complaintsrnThe Role Initiation, investigation and responding to customer complaintsMetric/dashboard maintenance; includes collecting data, producing graphs/charts/summarizing data and merging into uniform templates for management and senior management.Supports Regulatory Affairs Department through complaint handling associated with internal storage as well as coordination with off-site storage facility.Supports Quality Compliance department in tracking and reporting all document changes in the change control system.Supports Regulatory in responding to inquiries which includes investigating regulations, certifications and licenses at the Woodstock site and responding in written format via e-mail, memo or notarized letter.Performs return sample evaluations.Performs in depth investigations and root cause analysis for confirmed complaints.rnThe Candidate  Minimum High School Diploma, Associates Degree preferred.1-3 years Regulatory Affairs experience/Auditing Experience in the pharmaceutical industryMust be able to perform risk assessments in a timely manner and act accordingly.  Successful candidate will possess strong computer and appropriate communication skills (both written and oral) allowing direct interaction with outside suppliers, STW internal Managers and Sr. Management.Should be familiar with cGMP and safe work practices.Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software, etc) is preferred. TrackWise experience is a plus.rnQualified candidates will possess the following Catalent’s standard leadership competencies that are used to interview and for Performance & Development:Leads with Integrity and RespectDelivers ResultsDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and DevelopsrnPosition BenefitsMedical, Dental, Vision and 401K are all offered from day one of employment19 days of paid time off annuallyPotential for career growth within an expanding teamDefined career path and annual performance review and feedback processrnrnAbout Catalent 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. More products. Better treatments. Reliably supplied. ™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 along with the job number and title to ****. 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.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.

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