QS Document Control Specialist
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QS Document Control Specialist

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

Center for Breakthrough Medicines seeks a QS Document Control Specialist who is highly motivated and passionate to manage quality system and product supporting documentation. Reporting to the Director of Quality Systems, the Document Control Specialist is responsible for the implementation and management of controlled documents in accordance with CBM standard operating procedures and applicable GMP regulations.

Responsibilities

  • Maintain a GMP-compliant document management system
  • Plan and execute multiple tasks to ensure controlled documents are managed per procedures and applicable regulations.
  • Maintain controlled document files (hard copy and electronic)
  • Issue controlled documents in accordance with applicable procedures.
  • Manage the Document Management System according to procedure.
  • Act as Subject Matter Expert (SME) for document control and data integrity principles
  • As the SME, provide training to personnel on the document management system
  • As the SME, represent document control at internal meetings and during site audits.
  • Act as administrator for electronic systems used for document management
  • Develop and track goals and facilitates continuous improvements of the document management system
  • Provide support on various other projects as necessary, ensuring appropriate document control is maintained.
  • Other duties as required and necessary to ensure the success of the organization.

Qualifications

  • Bachelor’s Degree in a scientific or business field of study
  • 5+ years’ experience in the Pharmaceutical supporting GMPs or equivalent industry; 3+ years of experience in a document control position, preferred
  • Strong technical knowledge, skills and experience in project and documentation management
  • Direct experience with the use of Veeva Vault documentation system
  • Experience in Microsoft tools such as Outlook, Word, Excel, PowerPoint, SharePoint, Teams and Project is strongly recommended
  • Experience with document editing in MS word (e.g. formatting, forms, styles, templates, etc.)
  • Experience directly related to the development of Quality Standards and core requirements for Market Supply and / or Clinical Supply
  • Experience directly related to Quality Assurance, Quality Control, GMP regulations or pharmaceutical regulations
  • Knowledge of processing mapping and optimization
  • Working knowledge and understanding of GMPs for pharmaceuticals
  • Skilled in multitasking while maintaining attention to detail
  • Excellent organizational and time management skills
  • Skilled in effective communication, written and verbal
  • Demonstrated ability to work effectively with colleagues having a broad range of responsibilities, functional and cultural
  • Strong problem solving and customer service skills
  • Ability to use individual discretion in completing work assignments, establishing priorities, and working collectively to accomplish deadlines and objectives
  • Ability to change direction and respond to new situations which require immediate attention

Compensation: TBD

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