Sr. Quality Assurance Associate - Client Services and Operations

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 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. The Client QA contact 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. Responsible for being involved in and providing disposition for failure investigations. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Responsibilities include providing QA input to technology transfer documents, specifications, master/executed batch records, change requests, deviations and investigations. Shift work and/or weekend work may be required at times.

Key Responsibilities:

• Provides dedicated QA support to client projects and quality oversight of GMP operations for the manufacture of master/working
  cell banks, bulk drug substance and/or final drug product.
• Primary QA contact during client project lifecycle.
• Responsible for review and approval of master documents supporting the manufacture of products.
• Oversees the coordination and review of executed manufacturing documents, including delivery of such documents to clients.
• Supports and/or leads client on-site audits and participates in on-site technical visits.
• Facilitates resolution to quality issues and interfaces with the client to gain concurrence. Ensures that non-conformances are properly investigated and documented.
• Act as first responder and approval authority for quality issues and actively pursue timely, compliant closure and documentation
  of all events and investigations and required immediate corrective actions.
• Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP AND ICH Guidelines. EU GMPs a plus.
• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and/or fill/finish.
• Ability to function well under pressure in a changing environment.
• Creative individual with excellent analytical, problem solving, 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.
• Requires the ability to produce results in a fast-paced environment to meet client deadlines.
• Able to effectively interpret new and existing global regulations

Experience & Education:

• Minimum of a B.S. in a Life Sciences discipline
• 8 years' experience in a Quality Assurance role under GMP compliance supporting biologic products
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines

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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