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 Document Control Specialist maintains documents generated within the quality systems and by contract manufacturers and testing facilities according to internal processes and FDA regulations.
Key Job Responsibilities:
- Processes documents within MasterControl, the electronic document management system (eDMS).
- Reviews documents for accuracy and completeness in formatting and content.
- Coordinates through the change control process the revision, review, and approval of Standard Operating Procedures (SOP's), forms, spreadsheets, specifications and other document types.
- Maintains electronic and hard copies of controlled and uncontrolled documents and resource materials including those generated by outside contractors and vendors.
- Prepares status reports as directed.
- Assigns and records various document numbers in Excel sheets and Access databases.
- Assists with creation and presentation of yearly Good Manufacturing Practice (GMP) refresher training.
- Copies and distributes controlled reports, scans, and documents as needed.
- Maintains hard copy and electronic training files.
- Records, archives, and retrieves files at off-site storage facility (Iron Mountain).
- Performs other responsibilities as assigned.
Education / Experience / Professional Requirements:
- Bachelor's degree (or equivalent), with a minimum of 2 years of experience in a regulated industry, including 2 years of direct document control experience.
- Experience with document control activities is required.
- Document control experience within a change control process is strongly preferred.
- Familiarity with MasterControl or other eDMS preferred.
- Must be a strong user of Microsoft Word and Excel. Proficiency in Adobe Acrobat Pro and Microsoft Access databases are a plus.
- Excellent formatting, editing, and proof reading with a high degree of accuracy and completeness are essential.
- Requires strong written and verbal communication and interpersonal skills.
- Demonstrated ability to be flexible and adaptable, dealing effectively with frequent changes, delays, short timelines, or unexpected events.
- Must be able to follow established policies and procedures and comply with regulatory requirements.
- General understanding of FDA regulation requirements is preferred.
- Must be able to move/lift 45-50 lb. boxes of documents to a height of 53 inches.
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