Quality Systems Specialist
Posted on: March 15, 2020
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
Quality Systems Specialist
Catalent Paragon Gene Therapy is looking to recruit a Quality
Systems Specialist to join our growing team in Harmans, MD.
The Quality Systems Specialist responsible for supporting Quality
Systems, including investigation/deviation management, CAPA
tracking, and change control. This position will facilitate the
compiling, trending and reporting key quality metrics for
management, and other quality system functions, as needed.
Continuously monitor systems and procedures to ensure compliance
with applicable regulatory and industry standards, quality
improvements, and efficiency for phase appropriate GMP manufacture
of biological products.
The Quality Systems Specialist role is critical to our patients.
Ensuring compliance with quality systems with patient safety in
mind, executing with efficiency always. Quality, safety and on-time
delivery is a must to be successful in this role!
--- Supports administration for CAPA, Investigation, and Deviation
systems. Includes, facilitating the closure of items with the
applicable departments to ensure completion and timely
--- Responsible for tracking and trending aspects of the Quality
System and provide reports to management identifying risks and
trends on aroutine basis.
--- Performs CAPA effectiveness evaluation based on quantitative
and qualitative measurements.
--- Administer the Change Control process for the site and conduct
effectiveness verification for changes implemented.
--- Maintains tracking mechanisms to support various Quality
Systems elements and ensures visibility throughout the
--- Continuously monitor and review systems and procedures for
adherence to regulatory compliance, quality improvements,
efficiency and industry best practices.
--- Coordinates on-site client audits, preparation of audit
materials, and ensure timely response and resolution to client
--- Minimum of a B.S. in a Life Sciences discipline
--- 6 years' experience in a GMP environment with at least 4 of
those years in a Quality/Compliance function
--- Have the knowledge, and ability to apply basic scientific and
regulatory principles to improve quality systems
--- ASQ (American Society of Quality) or RAPS (Regulatory Affairs
Professionals Society) highly desirable
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
--- Potential for career growth within an expanding team
--- Defined career path and annual performance review & feedback
--- Cross functional exposure to other areas of within the
--- Medical, Dental, Vision, and 401K are all offered from day one
--- 19 days of paid time off annually + 7 paid holidays
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.
Keywords: Catalent, Severn , Quality Systems Specialist, Other , Severn, Maryland
Didn't find what you're looking for? Search again!