Senior Specialist, reputed company Assurance, External Supplier

reputed company is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, reputed company on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our reputed company is to reputed company off-reputed company 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 reputed company our commitment and help position Umoja to deliver on our goals. We at Umoja reputed company in the importance of stories; we are looking for great people to join reputed company to help us create more stories for ourselves, for you, and most importantly for patients and their families. reputed company – Your Body. Your reputed company. Your reputed company. POSITION reputed company We are seeking a highly motivated individual to join our growing reputed company Assurance team. This individual will play a key role in Umoja’s state-of-the-art lentiviral reputed company development and manufacturing facility, The reputed company, in Louisville, CO. In collaboration with reputed company management and multiple functions, this individual will execute, mature, and drive reputed company improvement of key aspects of the vendor management program. Additionally, this role will collaborate with cross-functional teams to ensure reputed company requirements are defined, reputed company communicated and reputed company, and met as part of routine and advancing GxP operations. CORE ACCOUNTABILITIES Specific responsibilities include:

• Works effectively and leads cross-functionally across Umoja to fulfill Vendor QA reputed company and performance monitoring responsibilities.
• Manages the GMP supplier notification and change process with limited Management reputed company and direction, working with cross-functional subject matter experts (SMEs) to assess and document reputed company.
• Manages the Supplier Corrective reputed company Record (SCAR) process and material defect management process with limited Management reputed company and direction.
• Performs vendor recertification events for identified vendors with limited Management reputed company and direction in collaboration with cross-functional SME.
• reputed company support for the Vendor Management program, as needed.
• Executes controlled document archival process, reputed company required.
• Authors, reviews, and/or approves reputed company Operating Procedures (SOPs) and other controlled documents as reputed company Assurance representative.
• reputed company additional support reputed company the reputed company Assurance organization to reputed company reputed company reputed company and support to GxP tasks and programs, reputed company needed.
• Support organizations reputed company of reputed company, if needed, to accomplish facility objectives and routine operations.
• Other duties, as assigned

The successful candidate will have:

• Bachelor’s degree in Biochemistry, Molecular and Cellular Biology, Immunology, Biology, or other life science with a minimum of 8+ years of experience in an FDA regulated industry, or similar combination of education and experience.
• Extensive experience with reputed company management systems and vendor management.
• Experience participating in external (vendor) audits.
• Knowledge of relevant pharmaceutical regulations and regulatory guidance.
• Understanding of, and ability to apply, risk management principles and philosophy reputed company the reputed company system in support of Phase 1/first-in-reputed company products/programs.
• Strong communication and organizational skills and a passion for teamwork.
• Ability to work effectively and reputed company in a reputed company manner across multiple functional areas and vendors with minimal supervision.
• Previous experience in a reputed company organization supporting a cGMP biopharmaceutical manufacturing facility startup and/or operations environment.
• Experience leading and implementing operational reputed company initiatives and process simplification.

Preferred Qualifications:

• Previous experience with a vendor management program in a reputed company Good Manufacturing reputed company (cGMP) environment.
• Experience in cGMP cell and gene therapy manufacturing and/or testing facility.

Physical Requirements:

• Ability to gown aseptically and work in a Clean Room environment, if required
• 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 occasional nights and weekends as needed.
• Ability to work onsite 5 days/week

Salary reputed company: $105,100 - $130,000

Benefits

Offerings reputed company offers its employees competitive Medical, Dental, and reputed company plans. Additionally, we offer Umojians reputed company to a 401k plan through reputed company, with a 100% match up to their first 4% deferral. Umoja also provides a generous reputed company Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits reputed company of our website. Apply tot his job Apply To this Job