As the Quality Assurance Specialist/Sr. Specialist, you’ll play a vital role in advancing Omeros’ portfolio of marketed and investigational products by ensuring compliance with regulatory requirements.
Good things are happening at Omeros!
Come join our Regulatory Affairs Group!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
Conducting audits of CMOs, CROs, and other service providers, writing audit reports and following up on observations/CAPAs
Performing in-phase inspections in support of GLP studies, writing inspection reports, following up on observations/CAPAs, and preparing QA statement
Reviewing GMP controlled documents such as master batch production records, test methods, specifications, and managing the implementation of required changes to meet GMP and internal standards
Reviewing executed batch production records ensuring compliance with approved procedures and GMP expectations as well as communicating and resolving discrepancies with the CMO
Reviewing release test and stability data ensuring data accuracy, conformance to test procedures, specifications, and documentation standards
Providing support in the review of change controls related to manufacturing
Providing QA support for validations including reviewing protocols and reports
Working collaboratively with Development, Manufacturing and QC staff, responding to and resolving deviations and incidents
Following through on corrective and preventative actions from deviations, OOS and audit observations
Maintaining databases for investigations, audit observations and CAPAs
Review, analysis and trending of data related to production, testing and stability
Writing and reviewing Standard Operating Procedures
What experience and education do you need?
You’ll need to have a BS and/or MS degree in Science and 5 years of related experience in Quality Assurance or a related area.
Additionally, we are seeking candidates with the following experience:
Prior audit and batch record review experience
In-depth knowledge and experience with GMP and GLP regulations and industry standards (USP, Ph.Eur., ICH, FDA, EU guidance)
What skills does our ideal candidate have?
As our ideal candidate, you’ll need the follow skills and knowledge:
Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software as well as internet search engines
Demonstrated analytical and problem solving skills
Detail orientation, organizational skills and the ability to prioritize multiple tasks
A demonstrated ability to build and maintain positive relationships with management, peers, subordinates, and others.
Excellent interpersonal, verbal and written communication skills
What else do you need to know?
Occasionally, you’ll be required to travel overnight
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!
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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine ...and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission (EC) has approved Omidria for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.