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 Senior Specialist, Quality Systems is responsible for leading/driving ongoing quality systems department activities in addition to acting as the Quality System (SME). Functional responsibilities include oversight of the change control process and customer complaint process, in addition to other quality systems (CAPAs; Deviations; Effectiveness Checks). The successful candidate will provide quality leadership and partner with functional quality and operations managers/stakeholders (internal or external) to assure compliance to established system requirements and to drive continuous improvement.
The role of the Senior Specialist, Quality Systems is critical to the end user which are our patients. It directly supports product and process quality. Quality, safety, and on-time delivery is a must to be successful in this role!
This new hire will report directly to the Quality Manager and will reside on-site at the Philadelphia, PA Clinical Supply Services site.
* Responsible for evaluating and managing new Quality System records/documentation, evaluating and entering Customer Complaints in TrackWise and seeking feedback/clarification from complainant as required.
* Ownership for evaluating Change Control requests and providing feedback to requestors on required information and documentation.
* Drive the Change Review Board (CRB) process, meeting and actions to execute and monitor Change Controls.
* Provide guidance and leadership as Quality System records progress through TrackWise to ensure compliance and alignment to Site and Global procedures.
* Responsible for developing / delivering training associated with current and new Quality Systems and for generating daily, weekly and monthly metrics and KPIs and identifying trends.
* Drive alignment and improvement initiatives associated with quality system workflows, including leading cross function teams/supporting Continuous Improvement team, to address process improvement or system improvement.
* Reviews and approves Events, Deviations, Complaints, Corrections, Actions and other records in TrackWise, as assigned. Partnering with all departments to provide technical and procedural support.
* Bachelor's Degree required or 7?10 years of relevant quality assurance experience. Minimum experience required: 5 years' experience in Quality Assurance in a GMP regulated environment.
* Computer Skills ? Experience with computer systems for the electronic management of Documents, Quality System records, and Training. Computer proficiency in Microsoft Office products (intermediate Word and Excel required).
* Previous experience with one or more of the following systems preferred; Documentum, TrackWise, ComplianceWire, SharePoint (or equivalent).
* Capable of quickly learning quality system software including Documentum, TrackWise and ComplianceWire.
* Ability to work effectively under high pressure with multiple deadlines. Ability to work cross-functionally with departments (Operations, Quality Assurance, Supply Chain, Engineering and Facilities) and individuals at all levels within Catalent.
We will identify candidates based on the following:
* Leads with Integrity and Respect
* Delivers Results
* Demonstrates Business Acumen
* Fosters Collaboration and Teamwork
* Champions Change
* Engages and Inspires
* Coaches and Develops
* Join a high growth and fast paced organization with a people focused culture
* Global exposure, defined career path and annual performance review and feedback process
* Competitive benefits, 401K and paid time off
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, and confirming your request for an accommodation and include the job number, title and location to ...@catalent.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.