Sr. Quality Assurance Specialist
This position performs a wide variety of activities to ensure compliance with applicable GxP and other regulatory requirements.
Good things are happening at Omeros!
Come join our Omeros Regulatory Affairs & QA Team!
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.
What are your job responsibilities?
- Review executed batch production records and test data ensuring compliance with approved procedures and GMP expectations, communicate and resolve discrepancies with CMO and contract testing laboratories
- Provide support in the review of master batch production records, test methods, and specifications
- Provide support in the review of change controls related to manufacturing and testing
- Work collaboratively with development, manufacturing and QC staff to respond to and resolve deviations and incidents
- Maintain databases for investigations, audit observations, and CAPAs
- Support the conduct and reporting of investigations related to product complaints
- Follow through on corrective and preventive actions from deviations, OOS and product complaints
- Review, analyze, and perform trending of data related to production, testing, and stability
- Write and review Standard Operating Procedures as needed
What education and experience do you need?
- University degree in science and a minimum of 8 years of experience for a Sr. Specialist in pharmaceutical/ biotech Quality Assurance or a related area
- Experience in review of batch records and change control
- Knowledge and experience with GMP regulations, and industry standards (USP, Ph. Eur., ICH, FDA, EU guidance)
- Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software, and internet search engines
- Excellent written and verbal skills required
Behavioral Competencies Required:
- Must have the ability to build and maintain positive relationships with
- management, peers, and subordinates
- Must display strong analytical, organizational, and problem-solving skills
- Self-motivated and able to function effectively within team
- Attention to detail is required
Physical Demands Required:
- May encounter prolonged periods of sitting
If you have the experience, skills and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!
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 either send an e-mail to firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000