Cascadian Therapeutics is a clinical-stage biopharmaceutical company specializing in developing innovative therapeutic product candidates for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our most advanced product candidate is tucatinib (ONT-380), an orally active and selective small molecule HER2 inhibitor. We are headquartered in Seattle, Washington. For more information, visit www.cascadianrx.com.
The Quality Assurance Associate/Senior Quality Assurance Associate will contribute their knowledge of GMP compliance and various regulatory requirements to help ensure that our products and vendors meet established standards of quality impacting the safety, identity, quality, strength, purity, or potency of the product being manufactured or tested.
Key Job Responsibilities:
- Assist in review of master and executed batch records and data resulting from contractor's manufacturing and testing of materials and products to ensure finished product quality. Communicate, track, and ensure timely closure of findings resulting from these reviews.
- Assist in maintenance and organization of Vendor Qualification Program: initiate contact with new vendors, request required information and ensure it is returned, review existing vendor's files for completion.
- Participate in external and internal quality audits, evaluate and document audit findings, collaborate on creation of Audit Reports, track and ensure implementation of appropriate corrective actions.
- Review, evaluate adequacy of, and suggest improvements to current Cascadian quality assurance standards and procedures in support of ongoing, late-phase clinical trials. Draft new quality assurance policies and procedures as required.
- Assure ongoing compliance with quality and industry regulatory requirements.
- Perform other job responsibilities as assigned.
Education / Experience / Professional Requirements:
- Bachelor's degree (or equivalent) in related field.
- Certifications preferred (e.g. Quality Auditor, Quality Engineer).
- Minimum of 3 years of related experience in life sciences industry.
- Proven experience working with and auditing contract manufacturing and testing organizations is essential.
- Experience with ongoing monitoring of Quality System programs (e.g. deviation, corrective action programs) as related to the stage of clinical trials and experience with late-stage products are a plus.
- Strong attention to detail is required.
- Excellent verbal and technical written communication skills and interpersonal skills are required.
- Requires proven problem analysis and problem solving skills.
- Good judgment and decision-making abilities are required.
- Customer service orientation and ability to work well independently and as part of a team are essential.
- Requires strong computer skills including Microsoft Office, Adobe Acrobat, EDMS (MasterControl), and databases.
- Knowledge of relevant regulatory requirements (GMP, ICH, and EU guidelines) is required.
Cascadian Therapeutics offers a comprehensive and highly competitive benefits package including medical, dental, vision care, life insurance, short and long term disability, stock options, ESPP, a matching traditional and ROTH 401(k) plan, and fully subsidized transit pass/parking.
If you are interested in working with our team in a collaborative and professional work environment, please Submit Resume ».
We are an Equal Opportunity Employer