Senior Associate, Quality Assurance

POSITION SUMMARY

Umoja Biopharma is seeking a highly motivated individual to join our growing Quality Assurance team. This individual will play a key role in Umoja’s state-of-the-art lentiviral vector development and internal GMP manufacturing facility, The CLIMB in Louisville, CO. This role will independently perform routine document control and training tasks, such as issuance, reconciliation, storage/archival, document review, and training assignment management. In close collaboration with Quality management, this individual will support the maturation and continuous improvement of the document control and training programs.  

This is a full-time onsite role based out of our Louisville, CO GMP manufacturing facility.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Effectively contributing within a high-performing GMP QA team, fostering a culture of quality, accountability, collaboration, and organizational flexibility & adaptability in alignment with Umoja’s values & principles and Umoja’s quality culture

• Performs routine document control activities, including controlled issuance, reconciliation, storage and archival.
• Performs routine training administration activities, including training assignment, maintenance of training requirements and curriculum.
• Reviews SOPs for adherence to document control procedural requirements.
• Assists with the revision of document control and training SOPs.
• Maintains the organization of the document control room, ensuring efficiency and effectiveness (i.e. documents are readily available)
• With oversight, provides guidance on document control and training procedures for other functions
• Collaborates with functional areas to ensure training assignments are appropriate. Responsible for maintaining the training matrix.
• Develops and delivers training in areas of proficiency (e.g., GDocP, document processing, technical writing)
• Provides document control support during preparation and execution of audits and inspections (i.e., document preparation).
• In collaboration with management, serves as Business Administrator and Training Administrator and supports improvements to the eLMS/eDMS.
• With guidance from Quality management, supports the maturation of document control and training programs.
• Supports the development and maintenance of performance metrics related to document control and training to drive continuous improvement.
• Supports the development of visual management tools and other business processes to increase effectiveness and efficiency of document control and training processes.
• May assist with other QA Activities to support the business, as needed
  • Material and product disposition
  • Administrative support for Quality Systems (e.g., coordination of triage, CCRB)
  • Quality Record review/approval
• Other duties as assigned

The successful candidate will have:

• Bachelor’s degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 3-6 years of work experience in GMP biotech or pharma setting. Equivalent combination of education and experience will be considered.
• Ability to identify areas for continuous improvement in document control and training and work with management to implement.  

• Experience using and electronic quality systems in support of internal GMP manufacturing operations (e.g., Veeva. Trackwise)
• Understanding of GMP requirements as they relate to document control and training in a GMP manufacturing environment.
• Experience in developing effective, concise training materials in areas of proficiency and delivering Instructor-Led training to audiences varying in size
• Ability to follow established procedures and business processes with limited direction from management.
• Ability to appropriately escalate through the decision-making process
• Ability to work and communicate effectively and efficiently in a collaborative manner across multiple functional areas

Preferred Qualifications:  

• Understanding of the concepts outlined in regulatory governing bodies guidance documents, laws, and regulations, and how to practically apply these in GMP manufacturing environment

Physical Requirements:  

• Ability to gown aseptically and work in a Clean Room environment
• Ability to work while gowned for extended periods of time, including standing for extended periods of time.
• Ability to sit in office setting for extended periods of time
• Ability to work weekends or evenings as needed
• Ability to work onsite 5 days/week

Salary Range: $76,000 - $93,900