Specialist, Quality Assurance

Catalent

Kansas City,MO  

2019-10-10 2019-11-09
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 Under general supervision, the Quality Assurance Specialist performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established SOP’s cGMP’s as necessary to accomplish daily tasks. Will work in a team environment to accomplish daily tasks. Must comply with divisional and site Environmental Health and Safety Requirements.







The Role





+ Responsible for the Quality support functions associated with the packaging of products for clinical and commercial batches



+ Performs batch record review, product release, and disposition



+ Assists in the execution of efficiency improvement projects with guidance



+ Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPs



+ Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines



+ Ensures gathering of data, investigations and deviations are timely and compliant



+ Performs review of validation protocols (pre-approval and post approval) to ensure data gathered meet applicable regulations and SOP’s.



+ Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines



+ Respond and interact with internal and external clients in a professional and timely manner









The Candidate



Education or Equivalent: Bachelor’s or a Master’s degree in a scientific discipline or equivalent knowledge and experience.



Knowledge/Skills Requirements:





+ Must be able to provide instruction, guidance and direction from/to others



+ Must be able to use existing procedures to solve routine and non-routine problems



+ Must be able to utilize all elements of the quality system to identify, classify and control the status of finished products produced



+ Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form



+ Mathematical and scientific reasoning ability



+ Ability to identify aberrant data and potential quality/compliance concerns escalating to management



+ Recognizes unmet needs within department and business



+ Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment.



+ Ability to work effectively under pressure to meet deadlines









Catalent’s standard leadership competencies





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops





Position Benefits:





+ 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.







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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