Specialist, Quality Assurance (Contract)

Umoja Biopharma

Louisville, CO

Posted: over a month ago
$107,000 to $131,000 Yearly
Contractor

Job Description

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Boulder, 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 Boulder, 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 the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

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 Contract Quality Assurance Specialist to support the start-up of Umoja's state-of-the-art lentiviral vector development and manufacturing facility in Louisville, CO. This position will provide quality oversight of incoming materials, commissioning & qualification, manufacturing, and general QA support of the start-up of Umoja's cGMP manufacturing facility.

REQUIREMENTS

Specific responsibilities include:

Reviews and approves material specifications, supplier corrective action requests, supplier qualification support, and performs material disposition.
Reviews and approves equipment qualification protocols and summary reports.
Reviews and approves CMMS records in support of CMMS asset induction.
Reviews and approves Master Batch Records, product specifications, process SOPs, and forms.
Interfaces with other departments (e.g., MSAT, Engineering, Facilities, Manufacturing, Regulatory Affairs, and Quality Control) to ensure compliance with all applicable procedures, policies, and standards.
Reviews and approves of Standard Operating Procedures.
Potential to transition to providing QA support of routine GMP manufacturing operations following start-up.
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 2 years of work experience in an FDA regulated industry.
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., audits/inspections, Change Control, Deviation/CAPA, etc.).
Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic startup environment.
Ability to work effectively and efficiently in a collaborative manner across multiple functional areas.

Preferred Qualifications:

Previous experience in a Quality organization supporting a cGMP biopharmaceutical manufacturing facility startup and/or operations environment.
Experience in cGMP cell and gene therapy manufacturing and/or testing facility.

Salary Range: $107,000 - $131,000 annually

This is a 6-month contract role.

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans through Premera Blue Cross, Delta Dental, and VSP. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a competitive, unlimited Paid Time Off policy, employee commuter benefits, and childcare reimbursement. For a full breakdown of our benefits offerings, please see the Benefits section of our website.