Quality Control Associate / Sr Quality Control Associate

Omeros•Seattle, WA

1d•Onsite

About The Position

Omeros is seeking a Quality Control Associate or Sr Quality Control Associate to join its CMC team at the Seattle headquarters. The role primarily reviews QC data packets and reports from external vendors and coordinates release and stability testing for clinical and commercial drug substance and drug product. It works with vendors and internal Quality partners to address documentation gaps, deviations, out-of-specification or out-of-trend results, and CAPA actions. The level of responsibility and independence will depend on experience and demonstrated capabilities. The position calls for hands-on experience with one or more physicochemical methods, including chromatographic, electrophoretic, and compendial assays, as well as familiarity with method troubleshooting. It also supports GMP investigations and oversight and provides non-GMP in-lab support for investigations and critical reagent management. At the senior level, responsibilities include managing analytical-method tech transfer, validation, lifecycle management, troubleshooting, and remediation at CROs and CMOs, with potential travel to external testing laboratories. This is an on-site position at Omeros’ Seattle headquarters. The role may involve working with and near hazardous materials and may require travel up to 10% of the time.

Requirements

BS or MS in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
At least 1 year of experience in a GMP/QC setting for QC Associate, or 3–6 years of experience in a GMP/QC setting for Sr QC Associate.
Experience reviewing or generating GMP laboratory records.
Technical and hands-on understanding of chromatographic assays (such as SEC, RP, peptide map, and CEX), electrophoretic assays (such as CE-SDS, SDS-PAGE, and icIEF), and compendial assays (pH, osmolality, bioburden, endotoxin, and sterility), including support of deviations and troubleshooting, specifically in protein and antibody characterization.
Demonstrated capability to review and interpret data and reports.
Familiarity with FDA/EMA regulations, ICH guidance documents, and US and EU compendia.
Excellent written and verbal skills.
Demonstrated problem-solving and multitasking capabilities.
Ability to build and maintain positive, collaborative relationships across functional areas, with management, and with external resources.
Detail-oriented, organized, adaptable, proactive, and self-motivated.

Nice To Haves

Experience with Waters Empower software.
Familiarity with Quality Management Systems and LIMS.
Familiarity with document change controls (DCCs) and method lifecycle management.

Responsibilities

Review and manage QC data to support GMP manufacturing.
Assist in overseeing release and stability testing of clinical and commercial drug substance and drug product at CROs and CMOs.
Assist in overseeing investigations, deviations, CAPAs, and OOS results related to release and stability testing.
Review data quality and integrity and perform data trending.
Manage material inventories and shipments and receipt of materials to and from external vendors.
Perform non-GMP in-lab testing to support internal investigations and critical reagent qualification or extension, documenting results under applicable protocols and procedures.
Ensure compliance with applicable regulatory guidelines, including relevant USP and ICH method guidelines and GMP codes of federal regulation.
At the Sr QC Associate level, manage tech transfer, method validation, lifecycle management, troubleshooting, and remediation of analytical methods at CROs and CMOs; this may include travel to external testing laboratories.