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Senior QA Specialist

3 months ago

Spring, United States Cellipont Bioservices Full time
Job DescriptionJob Description

Overview:

The Sr. QA Specialist is the quality lead for Client Projects from start to finish for phase appropriate GMP manufacture of cell therapies. This individual is the quality client liaison and with other Cellipont functions including Project Management, Process Development, Manufacturing, Quality Control, and other functions within the Quality 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.

Essential 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.
  • 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.
  • 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 Cellipont activities) and guidance bodies including ICH, ISPE, etc.
  • Support regulatory (i.e., FDA, EMA) and client audits/inspections.
  • Manage QA support for new product introductions at the site.
  • Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices.

Preferred Education and Experience

  • BS in a Life Science discipline
  • 6+ years quality experience within biopharmaceuticals

Knowledge / Skills Requirements:

  • Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance
  • Knowledgeable and/or exposure to biological manufacturing processes, such as cell and gene therapy, vaccine, cell banking, and aseptic fill finish
  • Exposure to contract manufacturing and facility build out is a plus.
  • Ability to quickly learn new and novel manufacturing processes supporting new clients
  • Ability to self-direct, and adapt to changing priorities · Excellent communication and interpersonal skills required
  • Strong attention to detail and organization skills required
  • Proven technical writing and editing skills
  • Creative individual with excellent problem solving and trouble shooting skills
  • Ability to work effectively under pressure to meet deadlines