Quality Assurance Specialist II

Sep 27, 2020
Required Education
Bachelors Degree
Position Type
Full time
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 QA Team!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

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
  • 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
  • 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
  • Domestic and international travel is 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.