Sr. Specialist, Quality Assurance

Location
Seattle, WA
Posted
Jun 28, 2022
Ref
1920
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

 

Sr. Specialist, Quality Assurance

 

 

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

 

 

Good things are happening at Omeros!

 

Come join our Omeros QA Team!

 

Who is Omeros? 

 

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 participates in a wide variety of activities supporting both clinical and commercial biologics programs, including:

 

  • Review executed batch production records ensuring compliance with approved procedures and GMP expectations; communicate and resolve discrepancies with third-party CMOs and GMP test labs
  • 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
  • Review and approve master label text and artwork for clinical packaging and labeling
  • 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
  • Provides 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 validations including reviewing protocols and reports
  • Provide support for external audits
  • Write and review Standard Operating Procedures as needed

 

Experience and Education Required:

 

  • BS and/or MS degree in Science and 5 years of experience in Quality Assurance or related area
  • Prior batch record review experience is required
  • Prior QA experience with late-phase or commercial large molecule biologics
  • Experience working with third-party CMOs and external GMP test labs
  • Drug Product 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

 

Skills and Knowledge

 

  • 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
  • Must display strong analytical and problem-solving skills
  • Good organizational and planning skills
  • Attention to detail required
  • Must be creative and participate in problem solving
  • Must have the ability to build and maintain positive relationships with management, peers, and subordinates
  • Self-motivated and able to function effectively within team

 

Behavioral Competencies Required: 

 

  • Domestic and international travel is required

 

Physical Demands Required:

 

  • May encounter prolonged periods of sitting

 

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