Sr. Quality Assurance Specialist - QA Operations

***This is an on-site role. The Sr. Quality Assurance Specialist will work a Hybrid schedule and will need to be local to the Seattle, WA area. ***

 Omeros is seeking a highly motivated individual to join the Quality Assurance team as a Sr QA Specialist to play a key role in supporting cGMP quality operations. The primary focus of the Sr QA Specialist role will be to support biologics programs to ensure consistent compliance with regulatory and industry expectations.

 

 

Good things are happening at Omeros!

 

Come join our Omeros Regulatory Affairs & QA Team!

 

 

About Omeros Corporation

 

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.

 

What are your job responsibilities?

 This position performs a wide variety of activities to ensure compliance with applicable GxP and other regulatory requirements.

• Review executed batch production records and test data ensuring compliance with approved procedures and GMP expectations, communicate and resolve discrepancies with third-party CMOs and GMP test laboratories
• Review release test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards
• Review and track manufacturing deviations and OOSs working collaboratively with internal staff to respond to and resolve deviations and OOSs
• Follow through on corrective and preventive actions from deviations and OOS 
• Provide support in the review and approval of cGMP-controlled documents such as master batch records, test methods, and specifications
• Provide support in the review of change controls related to manufacturing, test methods, and specifications to meet cGMP and internal standards
• Assist with the reporting and presentation of department metrics including annual product reviews
• Provide QA support for qualification and validations including reviewing protocols and reports
• Write and review Standard Operating Procedures as needed

 

What education and experience do you need?

 

• BS and/or MS degree in Science and 5 years of experience in Quality Assurance
• Prior batch record review experience is required
• Prior QA experience with late-phase or commercial large molecule biologics
• Experience working with third-pary CMOs and external GMP test labs
• Drug substance experience is a plus
• In-depth knowledge and experience with GMP regulations, and industry standards (USP, Ph. Eur., ICH, FDA, EU guidance)
• Excellent written and verbal skills required
• Must display strong analytical and problem-solving skills
• Attention to detail required

 

Behavioral Competencies Required: 

• The ability to interact cross-functionally in a positive manner
• Must have the ability to build and maintain positive relationships with management, peers, and subordinates
• Ability to identify issues and take appropriate actions, including escalation
• Good organizational and planning skills
• Must be creative and participate in problem solving
• Self-motivated and able to function effectively with a team

 Other requirements:

• Domestic and international travel is required

Physical Demands Required: 

• May encounter prolonged periods of sitting

 

Compensation and Benefits:

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Sr. Quality Assurance Specialist position is $95,000 to $120,000 per year. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision and life insurance and a 401k plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year.  This position is eligible for bonus and stock options. To learn more about Omeros, please visit www.omeros.com. 

If you have the experience, skills and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to    hr@omeros.com    or contact Omeros, asking for Human Resources, at (206) 676-5000