Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting-edge drug development. We are committed to our core values and principles that support our overall mission and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja to deliver on our goals. We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.
Umoja Biopharma – Your Body. Your Hope. Your Cure.
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
Benefits Offerings
Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 4% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.
