Job DescriptionWe are a fast-growing and dynamic organization seeking a
Quality Control Associate / Sr Quality Control Associate to join our CMC team. The role coordinates release and stability testing, reviews laboratory data packets and reports, and works with vendors and internal Quality partners to resolve documentation gaps, deviations, OOS/OOT results, and CAPA actions. Level and degree of independence will reflect experience and demonstrated capabilities.
This position will be primarily responsible for QC data review of data packets and reports from external vendors. The role has hands-on experience with performing one or more physicochemical methods such as chromatographic methods (SEC, RP-HPLC, peptide map, CEX), electrophoretic methods (CE-SDS, SDS-PAGE, and icIEF), and compendial assays (pH, osmolality, endotoxin, sterility) and will be familiar with method troubleshooting. This role will also assist the broader QC team with GMP investigations and oversight, and additionally, will assist with non-GMP in-lab support for deviations and critical reagent management. This position will be on-site at Omeros' Seattle headquarters.
What are your job 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 related to release and stability testing
- Review data quality and integrity and data trending
- Manage material inventories and shipment and receipt of material 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
- Ensuring compliance with all applicable regulatory guidelines, including relevant method USP and ICH guidelines, and relevant GMP codes of federal regulation
- For Sr QC Associate level, manage tech transfer, method validation, lifecycle management, troubleshooting, and remediation of analytical methods at CROs and CMOs, including potential travel to external testing laboratories
What education and experience do you need?- BS or MS in Chemistry, Biochemistry, Analytical Chemistry or 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
- Experience with Waters Empower software preferred
- Technical and hands-on understanding of chromatographic (such as SEC, RP, peptide map, CEX), electrophoretic (such as CE-SDS, SDS-PAGE, icIEF), and compendial (pH, osmolality, bioburden, endotoxin, sterility) assays, including support of deviations and troubleshooting, specifically in protein and antibody characterization
- Demonstrated capabilities of reviewing and interpreting data and reports
- Familiarity with FDA/EMA regulations, ICH guidance documents, and compendia (US, EU)
- Familiarity with Quality Management Systems and LIMS a plus
- Familiarity with document change controls (DCCs) and method lifecycle management a plus
- Excellent written and verbal skills required
Behavioral Competencies Required:- Demonstrated problem-solving and multi-tasking capabilities
- Ability to build and maintain positive and collaborative relationships across functional areas, with management and with external resources
- Detail oriented, organized, adaptable, proactive and self-motivated
Physical Demands Required:- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs
- May encounter prolonged periods of sitting
- This position requires working with and near hazardous material
- This position may require travel up to 10% of the time
Compensation and Benefits:Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for this position is (QC Associate: $85,000 - $94,000; Sr QC Associate: $95,000 - $120,000). Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for incentive and stock options. To learn more about Omeros, please visit www.omeros.com.
