Quality Assurance, Manager
Summary:
The Seattle Genetics Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients. The QA Manager position is responsible for staff oversight of manufacturing activities including batch production record review to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations. This position is also responsible for lot disposition.
Responsibilities:
- Oversee the following Manufacturing QA product activities:
- Review of cGMP Controlled Documents such as master batch production records, test methods, and specifications. Oversee and manage implementation of required changes to meet GMP and internal standards
- Review of executed batch production records to ensure compliance with approved procedures and GMP expectations including communication and resolution with CMO to resolve discrepancies
- Review and provide input into manufacturing deviations.Track open deviations through to final closure
- Review release data to ensure data accuracy, conformance to specifications and documentation standards
- Lot disposition
- Participate in internal audits; write audit reports and follow up on observations/CAPAs
- Participate in external audits of CMOs and other service providers; write audit reports and follow up on observations/CAPAs
- Report and present department metrics including Quarterly reports
- Create and revise Standard Operating Procedures as needed
- Represent QA and participate as QA Lead on CMC sub teams
- Participate in regulatory inspections
- Support electronic system continuous improvement activities (for example Change Management, Deviation/CAPA, QDM and ERP)
- Staff management and oversight including goal development and budgeting
Qualifications:
- Knowledge of cGMP and applicable FDA regulations
- Bachelor's degree in a scientific discipline or equivalent with 10
years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA - Detail oriented team player with effective planning, organization, and execution skills
- Excellent communication skills with internal and external personnel essential
- Experience with electronic documentation management systems (EDMS)
- Strong computer skills with Word and Excel
- Ability to work effectively at a fast pace with cross functional departments
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Ability to anticipate and mitigate challenges
- Experience supporting regulatory inspections desired
- Occasional travel up to 10% of time
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Estimated Salary: $20 to $28 per hour based on qualifications.
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