Job Title

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 Quality Assurance Specialist to support GMP operations at Umoja's state-of-the-art lentiviral vector development and GMP manufacturing and testing facility, The CLIMB, in Louisville, CO. This position will provide quality oversight of incoming materials, manufacturing, and general QA support of GMP operations at The CLIMB.This role is fully onsite based out of our Louisville, CO location.CORE ACCOUNTABILITIESSpecific responsibilities include: Exemplify and role model Umoja's quality cultureBuild strong, effective, and productive cross-functional working relationshipsInterfaces with other departments (e.g., Manufacturing, Supply Chain, Quality Control, Facilities, Engineering) to ensure compliance with all applicable procedures, policies, regulations, and standards.Provides QA "on the floor" support to Manufacturing during routine GMP operations at the site and Warehouse for material support and disposition.Reviews and approves work instructions, Standard Operating Procedures (SOPs), Material specifications, and other controlled documents related to GMP operations and other cGMP activities as neededPerforms disposition of incoming GMP materials Initiates Quality Holds as requiredProvides oversite on new material introductions including review and approval of new GMP material onboarding requestsPartners with Manufacturing to review and post-approve GMP executed batch records and protocolsReviews and approves Master Batch Records, process SOPs, and supporting forms for productsSupports line clearance/product changeover activities including the review and approval of associated documentationApproves work orders within Blue Mountain Regulatory Asset Manager (BMRAM), as neededReview and approves QC documentation (e.g., stability protocols) Provides Quality support to approve, review and close quality records (e.g., Change Controls, Deviations, and CAPAs, etc.) as necessary Identify, propose, and actively participate in opportunities for continuous improvementProvides additional support within the Quality organization, as neededThe successful candidate will have:Bachelor's degree in Engineering, Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with minimum of 5 years of work experience in an FDA regulated industryPrevious experience in a Quality organization supporting cGMP biopharmaceutical internal manufacturing facility operationsKnowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environmentAn understanding of foundational Quality systems (e.g., Good Documentation Practices, data integrity, audits/inspections, Change Control, Deviation/CAPA, etc.)Risk-based and practical decision-making capability, with an understanding on when decision making escalation is requiredAbility to work effectively and efficiently in a collaborative manner across multiple functional areasPreferred Qualifications: Experience in cGMP cell and gene therapy manufacturing facilityPhysical Requirements: Ability to work onsite 5 days/week at our Louisville, CO locationAbility to lift up to 20 lbs. on occasionAbility to stand for extended periods of timeAdherence to proper personal protective equipment (PPE) when necessary, such as but not limited to high-visibility safety vest, cold gloves, lab coat, safety glasses, gowning for manufacturing (scrubs, coveralls, hair net, beard net, etc), etc.Ability to support off-hours work on evenings, holidays, and/or weekends when necessarySalary Range: $85,300 - $105,300Benefits OfferingsUmoja 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.