"Document Control Specialist I"

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Document Control (DC) Specialist I is responsible for review and implementation of SOPs, reports, labels, forms, and protocols in support of the CTP Department.

Please note that this is a full-time (1.0 FTE) position, working Monday-Friday from 8:00am-4:30pm onsite at the South Lake Union location.

Responsibilities

• Performs technical writing and clerical/general departmental support for the preparation/revision of standard operating procedures (SOP) and other controlled documents.
• Maintain master files for controlled documents. Coordinate and perform document processing activities such as tracking status, initiating document revisions, issuing/distributing for approval and employee review and assuring implementation of documents.
• Maintain all paper systems according to cGTP regulatory and FACT accreditation requirements including the distribution and reconciliation of controlled documents.
• Coordinate biannual review process for SOPs, Batch Records, and Batch Record Worksheets.
• Perform quality control checks of paper and electronic files.
• Purchase office supplies for CTP Quality group and performs inventory control.
• Performs other related duties as needed.

Qualifications

Required:

• High School Diploma or equivalent
• 0-2 years of progressively complex administrative experience or equivalent.
• Attention to detail, with an ability to detect errors and inconsistencies in various types of documents. Strong computer, math and word processing skills.
• Excellent interpersonal, written, and verbal communication skills required.
• Extensive experience with PC based Microsoft Office applications, database software, and scanning systems.
• Ability to create and revise complex technical documents.
• Must be flexible, willing and able to work in team-based environment.
• Ability to prioritize among multiple projects and maintain deadlines.

Preferred:

• Associate's Degree or equivalent related work experience.
• One or more years of experience in the biotechnology or medical / pharmaceutical field.
• Knowledge of cGXP regulations and principles.

The hourly pay range for this position is from $35.09 to $52.63 and pay offered will be based on experience and qualifications.

This is a full-time (1.0 FTE) position, working Monday-Friday from 8:00am-4:30pm onsite at the South Lake Union location.This position is not eligible for H-1B sponsorship at this time.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).