Seagen

Quality Assurance Associate I

Description

Position Summary:

A Document Management Associate I is responsible for owning and managing the GMP Quality business processes supporting Quality Document Control authoring, review, and approval of GMP lifecycle documents.

The responsibilities include defining the corporate requirements for the Document Control program; making decisions within the scope of the program; providing customer service and user support by answering questions and providing guidance tools; developing metrics and assessing performance against them; authoring and collaborating on controlled procedures within scope of responsibility; participating on departmental or cross-functional teams; contributing to project milestones and continuous improvement activates; supporting audit and inspection requests; and interfacing with business process owners from other GxP programs.

Principal Responsibilities:

• Execute on defined and established procedures
• Process documents in electronic Document Management System
• Answer basic questions and send routine notifications
• Issue and reconcile batch records, forms, and logbooks
• Maintain and distribute documents to Controlled Document Locations
• Back-up the Records Management job function as required
• Collect data for metrics
• Contribute to milestones associated with specific projects
• Write or revise work instructions and templates
• Provide support for audits and inspections, as needed
• Participate in continual improvement activities
• Other duties as assigned

Qualifications:

• Knowledge of physical and electronic Document Management workflows and principles
• Knowledge of good documentation practices within the Pharma or Biopharma industries.
• Basic knowledge of continuous improvement principles and practices
• Advanced expertise with Office 365, especially Excel
• Experience with applicable software (e.g. Learning Management System, electronic Quality Management System, data analytics, etc.)
• Excellent written and oral communication skills
• Demonstrated problem-solving skills and techniques commensurate with job level

Preferred:

• Familiarity with cGMP and/or biotechnology industry
• Working knowledge of current industry practices and standards

Education

• Bachelor's degree in relevant field or equivalent experience; or 2+ years of relevant quality assurance, manufacturing, or quality control experience in the biotech or pharmaceutical industry

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com. 

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 02/19/2021