Catalent Pharma Solutions Quality Specialist II - Internal Audits/Vendor Management in Kansas City, Missouri
Quality Specialist II - Internal Audits/Vendor Management
Position Summary (Kansas City, MO)
The Quality Specialist II will report to the Manager, Regulatory Compliance
The individual in this position will support site compliance by performing internal audits of all GMP departments and quality systems per the site audit schedule and by supporting the Supplier Quality Management program through vendor management and external auditing.
The Role (daily responsibilities)
Provide support to the Vendor Management program, as applicable, to insure compliance with site and corporate procedures. This may include support of the following activities: formal supplier risk assessments, supplier deviations, management of supplier change notifications, maintenance of the site Approved Supplier list, and implementation and maintenance of Supplier Quality Agreements.
External Auditing (Supplier Audits)
Communicate with vendors to schedule and perform on-site audits to evaluate the facility, procedures, processes and quality systems.
Formal write-up of audit report, including assessment of vendor’s systems.
Follow up with vendor to ensure implementation of appropriate CAPAs as needed to close audit report.
Support internal audits (self inspections) of GMP departments and various quality systems in accordance with site audit schedule and applicable SOPs.
Review of department procedures/processes, SOP, Investigations, Complaints, Change Controls, Corrective and Preventive Actions (CAPA), equipment/instruments, logbooks, training records, management interviews, effectiveness checks, and other documents, as applicable.
Formal write-up of items reviewed and any audit findings, including follow-up to past year’s audit and CAPAs. Assignment of any applicable audit observations (including criticality), and approval of CAPA to correct deficiencies.
Oversee the Walk-Through Audit program to ensure area QA and Operations management perform walk through audits, per SOP.
Support other activities within the Compliance department, such as Quality Technical Agreements, Client audits, Regulatory inspections, state licensing.
The Candidate (requirements)
Minimum BS/BA in Related Field 1+ year of Internal/External Audit Experience under GMP regulatory requirements. Clinical and Commercial experience a plus.
Experience with Microsoft Word, Excel and Power Point. Experience with TrackWise, SharePoint and other software systems a plus.
15-20% travel is required
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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
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.
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.