Senior Specialist Manufacturing Quality Assurance
Acts as advisor to management and customers on advanced technical work, that performs review of documents, records, and procedures supporting release of clinical and/or commercial GMP products. Position also participates with a full understanding of GMP operations, and strong 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 advanced technical principles, theories, and concepts and contributes to the development of new principles and concepts. Represents the organization on advanced projects and/or programs. Demonstrates strong 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 high 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 the design of those goals and objectives. Assignments are largely established in accordance with schedules and deliverables and are often self-initiated.
- Perform MQA role to support cGMP production and testing operations
- 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 GMP and internal standards
- Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies
- Review/Approve Direct Material (i.e. raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards
- Compile or assist with managing lot files
- Lead/Assist labeling efforts of materials (i.e. raw materials, other) for production
- Assist with the reporting and/or presentation of department metrics
- Write and review Standard Operating Procedures as needed
- Provide MQA in plant support to support manufacturing operations
- Participate in audits: internal, external (vendor, partner), and regulatory inspections
- Other duties as requested
- Knowledge of cGMP and applicable FDA/international regulations
- Bachelor’s degree in a scientific discipline or equivalent with 10 years or more relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA
- Direct experience with 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
- Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems
- Strong computer skills (i.e. Word, Excel, Project, other)
- 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 working with clinical and commercial products and supporting regulatory inspections desired
- Experience with Lean-Six Sigma methodology preferred
- Experience with process validation activities (cleaning, viral, other)
- Ability to travel domestically and/or internationally up to 10% of time
- Ability to lift up to 25 Pounds
- Typically requires a minimum of 10 years of related experience with a Bachelor’s degree in a scientific discipline or equivalent.
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. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
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.