Quality Assurance Associate II/III

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 providing QA support for Client Projects and GMP Operations 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. 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.

Shift work and/or weekend work may be required at times.

Key Responsibilities:

• 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 quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.
• 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 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.
• Actively participates in client audits
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
• Creative individual with excellent analytical, trouble shooting, and decision making skills
• Ability to quickly learn new and novel manufacturing processes supporting new clients
• Able to work in a team setting and independently under minimum supervision
• Familiarity with electronic systems, including developing and producing reports using Microsoft Access and Excel

Experience & Education:

• Minimum of a B.S. in a Life Sciences discipline
• 4 years' experience in Quality Assurance in a GMP regulated environment for biologic products.
• Experience on the floor supporting GMP Manufacturing compliance through Batch Record Review, Deviations, CAPA
• 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.

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