Seagen

QA Specialist

Description

Summary:

The successful candidate will perform QA review of documents, records, and procedures supporting release of clinical and/or commercial GMP products. Position also participates with a understanding of GMP operations, and ability to resolve a wide range of issues in creative ways.

Developing professional expertise, applies company policies and procedures to resolve a variety of work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Applies technical principles, theories, and concepts and contributes to the development of new principles and concepts. Represents the organization on projects and/or programs. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with internal and external personnel in own area of expertise.   Contributes to the completion of specific programs and projects of complex nature, where independent action and a degree of initiative are required in resolving problems and developing recommendations.

Work is reviewed for accuracy and completeness. Can develop advanced technological ideas and guides their development into a final product. Works under consultative direction toward predetermined long-range goals and objectives and contributes to those goals and objectives. Assignments are largely established in accordance with schedules and deliverables and are often self-initiated.

Principal Responsibilities:

• Review/Approve deviations, CAPAs, and change controls. Monitor open quality system records to closure
• Review/Approve executed batch production records to ensure compliance with approved procedures and cGMP expectations
• Compile or assist with managing lot files
• Review/Approve controlled documents such as master batch production records, SOPs, test methods, specifications
• Review receiving and testing documentation, label, and disposition Direct Materials (i.e., raw material, other)
• Provide MQA in plant support to support manufacturing operations 
• Assist with reporting and/or presentation of department metrics
• Participate in audits: internal, external (vendor, partner), and regulatory inspections
• Other duties as requested

Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent with 7years or more relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA
• Knowledge of cGMP and applicable FDA/international regulations
• Experience with clinical and commercial plant operations, pharmaceutical/biotechnology manufacturing, and analytical testing a plus
• Detail oriented team player with effective planning, organization, and execution skills
• Excellent communication skills with internal and external personnel essential
• Ability to work effectively at a fast pace with cross functional departments
• Innovative, proactive, and resourceful: committed to continuous improvement
• Experience with quality management systems (QMS), electronic documentation management systems (EDMS)and inventory management systems
• Experience supporting audits and regulatory inspections
• Ability to travel domestically and/or internationally up to 10% of time
• Experience with process validation activities (cleaning, viral, other)preferred
• Experience with Lean-Six Sigma methodology preferred
• Ability to lift up to 25 Pounds

Seagen, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in people’s lives. Learn more about Seagen at www.seagen.com.

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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.

Seattle Genetics 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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/15/2021