Quality Assurance Specialist/Sr. Specialist – GLP/GMP
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 Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing 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.
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