Quality Control Associate Sr Quality Control Associate

Description

We 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.

Good things are happening at Omeros!

Who is Omeros

Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications with a focus on complement-mediated diseases cancers and addictive or compulsive disorders. Omeros lead complement inhibitor YARTEMLEA (narsoplimab-wuug) which targets the lectin pathways effector enzyme MASP-2 is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029 Omeros long-acting MASP-2 inhibitor has successfully completed Phase 1 clinical trials.

Under an asset purchase and licensing agreement Novo Nordisk acquired global rights to zaltenibart (formerly OMS906) an inhibitor of MASP-3 the alternative pathways key activator which is in clinical development for PNH and other alternative pathway indications along with associated intellectual property and related assets. Omeros pipeline also includes OMS527 a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder which is fully funded by the National Institute on Drug Abuse and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs visit .

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
• E xperience 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: $85000 $94000; Sr QC Associate: $95000 - $120000). 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 .

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 send an e-mail to

Required Experience:

Senior IC