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Quality

Senior Specialist, Quality Assurance Operations

  • RTP, NC
  • Added
Asset 1

Position Overview:

The Senior Specialist, QA Operations will be responsible for supporting Quality’s oversight of laboratory and manufacturing operations at Beam’s manufacturing facility in RTP, North Carolina.  The NC manufacturing facility is a greenfield build and will build out in various phases over a 6-8 Year period, with a focus on advanced therapeutic manufacturing technologies (cell and gene therapy modalities).  The facility will start as a clinical phase manufacturing plant with the intent to move several programs to commercial within the same facility.

The role will support plant start-up, program tech transfer, and routine operations thereafter to ensure that systems and processes are maintained to ensure compliance to Good Manufacturing Practices, and ultimately to Good Distribution Practices as the programs move to the commercial phase.  The role will cover aspects of the QA Operations team, approval of OOS investigations and test data review, approval of validation protocols, supporting product disposition, Plant floor Quality presence, batch record review, approval of associated deviation / investigations and release of incoming raw materials and consumables, as necessary. The role will initially focus on the Lipid Nanoparticle (LNP) platform and grow with future modalities and programs. The position will report into Beam NC, QA Operations Director.

The Senior Specialist, QA Operations is expected to be an on-site resource for project start-up and routine clinical and commercial operations.

Primary Responsibilities:

  • Individual will partner with other functional areas for site start-up activities, quality risk management, ongoing continuous improvement and future scale-up as well as for problem resolution.
  • Provide QC operations oversight and quality oversight of manufacturing on the floor activities including plant presence during operations.
  • Responsible to ensure GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
  • Responsible for assisting with product disposition activities of supply produced at the manufacturing facility:
    • Real time review of batch records and labels.
    • Review and approval of manufacturing discrepancies, laboratory investigations, and change controls.
    • Communicating lot disposition pending issues to management.
  • Aid in the development and ongoing improvement of applicable quality systems for the site; identifying gaps or improvements, authoring and approval of procedures, and providing training.
  • Review and approve validation protocols, calibration and maintenance work orders and asset inductions.
  • Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues.
  • Responsible for supporting functional and facility goals and objectives.
  • Responsible for supporting and contributing to quality metrics for the facility. 
  • Responsible to support and participate in regulatory inspections.
  • Responsible for communicating escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image to senior management.

Qualifications:

  • Bachelors or Advanced degree in a scientific discipline.
  • 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality. Knowledge of analytical testing, aseptic processing, and/or cell and gene therapy is preferred.
  • Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
  • Experience interacting with regulatory health authorities inspections.
  • Knowledge of global regulations and standards.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
  • Excellent listening, communication and interpersonal skills fostering team spirit.
  • Consistent delivery of high-quality work at all times.
  • Ability to gown and work in a cleanroom environment.
  • Must be willing to have a flexible schedule during initial site start up, which may include supporting critical operations outside of normal work hours, as needed

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