Catalent Pharma Solutions Quality Specialist II in Kansas City, Missouri
Quality Specialist II
Reporting to the Group Leader, the Quality Specialist II will support Catalent site compliance through the Internal Auditing and Supplier Quality Management programs.
The Role (daily responsibilities)
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.
Perform 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 Supplier Quality Management Program in accordance with applicable SOPs.
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, assessment of vendor’s systems.
Follow up with vendor to ensure implementation of appropriate CAPAs as needed to close audit report.
Perform supplier risk assessments using supplier questionnaires and other supplier related information (previous audits, deviations, complaints, etc...)
Manage and assess impact of supplier change notifications related to the Kansas City site.
Management of the Approved Supplier list to ensure supplier information is up-to-date and accurate.
Contribute to the evaluation of the annual Supplier Quality Agreement assessment.
Ensure that site procedures related to supplier quality management are aligned with global policies.
Support other activities within the Compliance department, which may include providing internal/external audit metrics for Site and Corporate management, and supporting regulatory inspections, client audits and other quality or regulatory activities as needed.
The Candidate (requirements)
Minimum BS/BA in Related Field and 1+ year of Internal/External Audit Experience under GMP regulatory requirements. Clinical and Commercial experience a plus.
Computer skills – Experienced with Microsoft Word, Excel, Access, and PowerPoint. Experience with TrackWise, SharePoint and other software systems a plus.
GMP compliance –The employee is required to be trained on all related GMP SOPs and must abide by the rules and regulations associated with the maintenance of these documents. GMP regulatory knowledge base in US, European, and other countries a plus.
Catalent’s standard leadership competencies:
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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 = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
Grow with us. Be challenged. Make a personal impact.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here
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.