Sr. Quality Assurance Associate - Product Lead (GMP)

Location
Harmans, MD, US
Posted
Sep 18, 2019
Ref
1798
Hotbed
BioCapital
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.

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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