Quality Assurance Associate III/Sr. Associate - Client Projects

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 serving as a quality lead for Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. This position serves as the dedicated Client QA Representative and liaisons with the Client and other Paragon functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. This position has the responsibility and authority to review and disposition GMP batches. Drives and participates in continuous quality improvement initiatives Shift work and/or weekend work may be required at times. ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products.

Key Responsibilities include but are not limited to:

• Represents QA in client interactions and meetings. Primary responsibility is to provide QA oversight and support to client projects while working closely with QA Management to ensure QA support for GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product used for human consumption.
• Works cross-functionally with Project Management, Pre-Clinical Services, Manufacturing, Facilities, Quality Control and other departments to execute client project activities in accordance with timelines
• Facilitates resolution to quality issues and interfaces with the client to gain resolution. Ensuring that non-conformances are properly investigated and documented.
• Perform review and approval of client master batch record, master manufacturing records, specifications, and other required documentation.
• Act as first responder and approval authority for all quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions.
• Identify compliance risks to management with remediation proposal, and lead solution implementation.
• Conducts review/approval of executed batch records and supporting documentation for accuracy, completeness, and compliance; as required.
• Supports GMP departments in performing, and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).
• Develop standard work practices to ensure high and consistent level of quality is maintained.
• Provide training in standard work specifics. Support, participate in, and approve compliance-critical efforts.
• Supports and/or leads client on-site audits and participates in on-site technical visits.
• Support regulatory (i.e. FDA, EMA) inspections of Paragon.
• Collaborate with other members of the QA Unit, including cross training where necessary, for performing duties and tasks in support of Paragons Quality Systems, such as review of validation master/executed protocols and reports
• Maintains systems used for tracking various GMP manufacturing associated support activities.
• Generation and/or revise document in accordance with cGMPs
• Support Pre-Clinical QA when needed during initial process development and non-clinical batch production. Primary responsibility to support engineering runs, technology transfer and GMP manufacturing
• Proactively lead quality improvement projects.
• Evaluate and perform compliance-related data trend analysis and report results. Make recommendations and drive implementation based upon findings.
• Track and evaluate any non-conformances that occur during the manufacture of drug product.
• Track and evaluate change controls as they impact the project.
• Lead and participate in site quality and process improvement initiatives to ensure compliance and efficiency.
• Stay current with changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to Paragon activities) and guidance bodies including ICH, ISPE, etc.
• Manage QA support for new product introductions at the site.

Education & Experience:

• Bachelor in a Life Sciences discipline
• 8 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with 6 years' experience in Quality Assurance function preferably on the floor operations
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
• Familiarity with compliant 21 CFR Part 11 electronic systems
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks

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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