Quality Systems Specialist
Company: Paragon BioServices, Inc.
Posted on: June 15, 2019
Paragon Gene Therapy, now a part of Catalent, hires people with a
passion to make a difference. Your expertise, coupled with our
advanced technologies and collaboration with 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. Paragon Gene Therapy, in Baltimore &
Harmans, Maryland, provides industry-leading GMP development and
manufacturing services for cutting-edge biopharmaceuticals such as
recombinant viral vectors, next generation vaccines &
hard-to-express recombinant proteins and oncolytic viruses. This
role is 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. KEY
- 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.
- Participate in compliance remediation plans and
- Assists with the generation and/or revision of GMP
documentation such as standard operating procedures.
- Coordinates on-site client audits, preparation of audit
materials, and ensure timely response and resolution to client
- Assists with performing internal audits.
- Works cross-functionally with departments to review and improve
upon Quality System metrics
- Participate in site quality and process improvement
initiatives. Represent QA on site project teams.
- Other duties as assigned EDUCATION & EXPERIENCE:
- 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 Paragon Bioservices is
proud to be an Equal Employment Opportunity and Affirmative Action
employer. We do not discriminate based upon race, religion, color,
national origin, gender (including pregnancy, childbirth, or
related medical conditions), sexual orientation, gender identity,
gender expression, age, status as a protected veteran, status as an
individual with a disability, or other applicable legally protected
Keywords: Paragon BioServices, Inc., Baltimore , Quality Systems Specialist, Other , Baltimore, Maryland
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