Catalent Pharma Solutions Compliance Coordinator in Woodstock, Illinois

Job Description

Job Title

Compliance Coordinator

Position 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 complaints

The Role

  • Initiation, investigation and responding to customer complaints

  • Metric/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.

The Candidate

  • Minimum High School Diploma, Associates Degree preferred.

  • 1-3 years Regulatory Affairs experience/Auditing Experience in the pharmaceutical industry

  • Must 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.

Qualified candidates will possess the following 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

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

About 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 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 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.

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 offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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.