Catalent Pharma Solutions Associate, Quality Assurance in Kansas City, Missouri
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
Under general supervision, the Quality Assurance Associate performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. This role requires the Quality Assurance Associate to perform some evaluation, originality or ingenuity is required. Follows established protocols and work plans.
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
Reviews production logbooks for GMP compliance as each operation is completed and revises SOPs as needed
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
Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing)
Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
Education or Equivalent: Bachelor’s degree in a scientific discipline or equivalent knowledge and experience.
Experience: Bachelor’s degree in a scientific discipline with 0-2 years Quality Assurance experience in a GMP manufacturing environment; or a high school degree with 2+ years of Quality Assurance experience in a GMP manufacturing environment. Six Sigma or ASQ certification preferred.
Uses existing procedures to solve routine problems
Proactive to address work issues at the individual level
Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form
Ability to identify aberrant data and potential quality/compliance concerns escalating to management
Excellent written and verbal communications skills with internal and external customers, peers and managers
Has sufficient skills and knowledge in the use of computers and associated computer technology. Computer technology relates to both the hardware and software used in performing common computing tasks. (Word, Excel, Outlook, Power Point basics)
Catalent’s leadership competencies
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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.
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.