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Quality Assurance Systems - Audit Management

Company: Catalent
Location: Madison
Posted on: January 16, 2020

Job Description:

Job DescriptionPosition Overview:-- 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 hereThe Quality Assurance Systems- Audit Management Senior, Specialist, is responsible for all quality assurance and quality control functions at Catalent, Madison. The role assures that all operations at Catalent meet or exceed cGMP regulations and customer requirements.In concert with Catalent---s Patient First philosophy, The Quality Assurance Systems- Audit Management Senior, Specialist safeguards all systems, processes and actions to ensure regulatory compliance is met, which is essential in providing high quality drug products for our clients and their patients.The Role Manages and Executes internal and external audits including external customers and suppliers Hosting customer audits by coordinating the audit with the customer and internal Catalent stakeholders Meets or exceeds all Catalent---s cGMP regulations and customer requirements Works cross functionally with other departments to identify risk to ensure corrective and preventive actions are implemented Project review for accuracy and compliance System implementation, maintenance and site wide training Reporting metrics for implementing improvement opportunities of processes, procedures, training to CAPA, Change Control, risk management and deviation processesThe Candidate Master's Degree in technical discipline (biology, biotechnology, engineering) or related life field with a minimum of eight years--- related experience; or bachelor---s degree in technical discipline with minimum of ten years--- related experience Customer Interfacing experience - working with outside customers and suppliers for audit implementation, coordination and corrective action, Working ---Hands ON--- within a manufacturing field (Preferred) Start to Finish Audit Management (Audit Project Management) - PreferredCatalent---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 DevelopsPosition Benefits Fast tracked career growth, with annual performance review and feedback process Competitive base salary with other compensation incentives including yearly incentive plan Medical, Dental, Vision, and 401K are all offered on day one of employment 19 days of Paid Time Off (PTO) + 7 paid holidays Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention! Defined career path and annual performance review and feedback processCatalent 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.-- ---- --personal initiative. dynamic pace. meaningful work.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 DisabilityAccommodations@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.

Keywords: Catalent, Madison , Quality Assurance Systems - Audit Management, Executive , Madison, Wisconsin

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