Specialist, Quality Assurance Validation

Catalent

Madison,WI  

2019-11-07 2019-12-07
quality administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



Job Description

Position 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 here











Position Summary







The Specialist, Quality Assurance Validation is responsible for all quality assurance and quality control functions at Catalent, Madison. The Department’s primary function is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material, Master Cell Bank, and API release.







The Specialist, Quality Assurance Validation participates in the completion of milestones associated with specific projects and supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role contributes to the development of concepts and techniques specific to validation and risk management and completes tasks in a creative and effective way. The QA Validation Specialist serves as the quality contact for quality projects and continuous improvement efforts regarding Validation and Quality Risk Management.







In concert with Catalent's Patient First Philosophy, Specialist, Quality Assurance Validation is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients. The Validation Department ensures that regulatory compliance is maintained for the implementation of new systems and changes to existing systems which are used for the manufacture of drug products.







The Role





+ Provides guidance and appropriate oversight for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.



+ Maintains and enhances validation programs for existing equipment, utility commissioning and qualification, and computer systems.



+ Assists in the development of a process validation program including assessments of Critical Quality Attributes and Critical Process Parameters.



+ Drafts, reviews, executes and approves protocols and reports related to equipment, facility, method, computer, and process validation. This includes deviation reporting during execution.



+ Acts as Quality contact and primary Subject Matter Expert (SME) for Validation and Quality Risk Management.









The Candidate





+ Master's Degree in technical discipline (e.g. e.g. biology, biotechnology, engineering) or related field with minimum of 4 years’ related experience; or



+ Bachelor's Degree in technical discipline (e.g. e.g. biology, biotechnology, engineering) or related field with minimum of 7 years’ related experience.









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





+ 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 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.







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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





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!







personal initiative. dynamic pace. meaningful work.







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.
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