Quality Control Associate / Sr Quality Control Associate

Omeros•Seattle, WA

11h•$85,000 - $120,000•Onsite

About The Position

Omeros is seeking a Quality Control Associate or Senior Quality Control Associate to join its CMC team at the company’s Seattle headquarters. The position coordinates release and stability testing, reviews laboratory data packets and reports, and works with external vendors and internal Quality partners to resolve documentation gaps, deviations, out-of-specification or out-of-trend results, and CAPA actions. The level of responsibility and independence will reflect the successful candidate’s experience and demonstrated capabilities. The role primarily reviews QC data packets and reports from external vendors. It calls for hands-on experience with one or more physicochemical methods, including chromatographic, electrophoretic, and compendial assays, as well as familiarity with method troubleshooting. The employee also supports GMP investigations and oversight and provides non-GMP in-lab assistance with deviations and critical reagent management. At the Senior QC Associate level, the role additionally manages analytical-method tech transfer, validation, lifecycle management, troubleshooting, and remediation at CROs and CMOs, with potential travel to external testing laboratories. The position is on-site at Omeros’ Seattle headquarters. Travel may be required up to 10% of the time. The position involves working with and near hazardous materials and intermittent physical activity, including bending, reaching, pushing, pulling, or lifting up to 40 pounds; prolonged sitting may also occur.

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 Senior 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 such as pH, osmolality, bioburden, endotoxin, and sterility, including deviation support and troubleshooting, specifically in protein and antibody characterization.
Demonstrated ability to review and interpret data and reports.
Familiarity with FDA and 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.
Ability to perform intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs; may encounter prolonged periods of sitting and work with and near hazardous materials.
May be required to travel up to 10% of the time.

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 issues related to release and stability testing.
Review data quality, data integrity, and data trending.
Manage material inventories and the shipment 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 Regulations.
At the Senior QC Associate level, manage tech transfer, method validation, lifecycle management, troubleshooting, and remediation of analytical methods at CROs and CMOs; travel to external testing laboratories may be required.