Quality Control Associate / Sr Quality Control Associate

Omeros Corporation; Washington; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) plan with company match

Vacation and holidays

Stock options / incentive program

Job summary

Omeros Corporation in Seattle, WA seeks a Quality Control Associate / Sr Quality Control Associate to join the CMC team. The role performs QC data review of data packets, oversees release and stability testing with CROs/CMOs, and supports GMP investigations and CAPAs. On-site work at our Seattle headquarters is required.

The position requires hands-on chromatographic and electrophoretic methods experience and familiarity with USP/ICH GMP guidelines. Travel may be required for senior duties.

Qualifications

• BS or MS in Chemistry, Biochemistry, Analytical Chemistry or related field.
• At least 1 year of GMP/QC experience for QC Associate or 3–6 years for Sr QC Associate.
• Experience reviewing or generating GMP laboratory records.
• Experience with Waters Empower software preferred.
• Technical understanding of chromatographic, electrophoretic, and compendial assays with support of deviations and troubleshooting.

Responsibilities

• Review and manage QC data to support GMP manufacturing.
• Assist in overseeing release and stability testing at CROs/CMOs.
• Assist in investigations, deviations, CAPAs, and OOS related to release and stability testing.
• Review data quality and trend data integrity.
• Manage material inventories and shipment/receiving with external vendors.
• Conduct non-GMP in-lab testing to support internal investigations and reagent qualification.
• Ensure compliance with applicable regulatory guidelines, USP and ICH, and GMP.
• For Sr QC Associate, manage tech transfer, method validation, lifecycle management, troubleshooting, and remediation at CROs/CMOs; may travel.

Skills

QC data review

GMP investigations

Electrophoretic methods

Chromatographic methods

Documentation updates

Education

BS or MS in Chemistry/Analytical Chemistry

Tools

Waters Empower

Job description

Quality Control Associate / Sr Quality Control Associate

Seattle, WA, United States

Job 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 pathway's 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 pathway's 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 www.omeros.com.

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


• 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.

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 [e-mail].