Specialist, Quality Assurance

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 ACCOUNTABILITIES
Specific responsibilities include:  

• Exemplify and role model Umoja’s quality culture
• Build strong, effective, and productive cross-functional working relationships
• Interfaces 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 needed
• Performs disposition of incoming GMP materials  
• Initiates Quality Holds as required
• Provides oversite on new material introductions including review and approval of new GMP material onboarding requests
• Partners with Manufacturing to review and post-approve GMP executed batch records and protocols
• Reviews and approves Master Batch Records, process SOPs, and supporting forms for products
• Supports line clearance/product changeover activities including the review and approval of associated documentation
• Approves work orders within Blue Mountain Regulatory Asset Manager (BMRAM), as needed
• Review 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 improvement
• Provides additional support within the Quality organization, as needed

The 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 industry
• Previous experience in a Quality organization supporting cGMP biopharmaceutical internal manufacturing facility operations
• Knowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment
• An 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 required
• Ability to work effectively and efficiently in a collaborative manner across multiple functional areas

Preferred Qualifications:  

• Experience in cGMP cell and gene therapy manufacturing facility

Physical Requirements:  

• Ability to work onsite 5 days/week at our Louisville, CO location
• Ability to lift up to 20 lbs. on occasion
• Ability to stand for extended periods of time
• Adherence 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 necessary

Salary Range: $85,300 - $105,300