Quality Assurance Specialist/Specialist II

Quality Assurance Specialist/ Specialist II

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!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

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 at least 2 - 7 years of experience in pharmaceutical/ biotech Quality Assurance or 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

Other Requirements:

• The employee is required to travel overnight

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000