Quality Systems Specialist

Paragon Bioservices, Inc. (PBI) is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Paragon Bioservices provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

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 RESPONSIBILITIES:

• Supports administration for CAPA, Investigation, and Deviation systems. Includes, facilitating the closure of items with the applicable departments to ensure completion and timely resolution.
• Responsible for tracking and trending aspects of the Quality System and provide reports to management identifying risks and trends on a
  routine 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 organization
• 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 implementation.
• 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 observations.
• 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 characteristics.

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