Quality Associate III

Description

Position at Seagen

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

• The successful candidate will perform review of documents, records and procedures supporting disposition of clinical or commercial cGMP products and participate in cGMP operations, as assigned

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Contributes to the completion of specific programs and projects

• Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex tasks in creative and effective ways

• Normally receives no instruction on day-to-day work, general instructions on new assignments

• Independently determines and develops approach to solutions

• Individual contributor with no people management responsibilities

Principal Responsibilities:

• Perform QA role to support cGMP production and testing operations

• Provide QA in plant support for manufacturing operations

• Review executed batch production records to ensure compliance with approved procedures and cGMP expectations. Communicate and resolve discrepancies

• Compile or assist with managing lot files

• Review/Approve Direct Material (., raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards. Disposition and status label materials post disposition

• Work with internal cross functional teams to resolve issues and identify corrective actions

• Review and Approve deviations, CAPA, and change controls. Monitor responsible open quality system records to closure

• Review cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet cGMP and internal standards

• Write and review Standard Operating Procedures as needed

• Assist with the 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 5 years 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

• Direct experience with plant operations, pharmaceutical/biotechnology manufacturing and analytical testing a plus

• Experience working with clinical and/or commercial products

• 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

• Ability to anticipate and mitigate challenges

• Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems

• Strong computer skills (., Word, Excel)

• Ability to work weekends, evenings, holidays or overtime, as needed

• Ability to lift up to 25 Pounds and gown into manufacturing plant

• Ability to travel domestically and/or internationally up to 10% of time

Education:

• Bachelor’s degree in a scientific discipline or equivalent

The hiring pay range for this position is $88,000 - $114,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire and an annual bonus.