Quality Assurance Associate - GMP

Harmans, MD, US
Sep 18, 2019
Required Education
Masters Degree/MBA
Position Type
Full time
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.

Quality Associate II (QA Operations) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA 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.

This is a first shift position

Key Responsibilities include but aren't limited to:

  • Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.
  • Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.
  • Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance.
    Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.
  • Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
  • Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.
  • Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.
  • Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product.
  • Write, revise and approve GMP documentation as necessary
  • Works cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner
  • Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.
  • Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

Education & Experience:

  • Minimum of a B.S. in a Life Sciences discipline
  • 2 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with experience ensuring compliance for GMP manufacturing processes
  • Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
  • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
  • Exposure to Lean Operational Excellence 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.