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Senior Specialist, Quality Assurance Specialist
2 months ago
Job Summary
The Senior Specialist for the Quality Assurance Sterility Assurance group is an individual contributor role responsible for the quality oversight of the site contamination control strategy, including Environmental Monitoring (EM), EM investigation program, support for contamination events, and quality risk assessments.
Key Responsibilities
- Quality oversight and support for programs such as cleaning and disinfection, gowning, access and flow, facility modifications, qualifications, disruptions, and shutdowns.
- Quality oversight and support of Environmental Monitoring Excursion Investigation Program, including CAPA creation and management.
- Quality oversight and support for contamination investigations/CAPAs/effectiveness checks associated with, but not limited to environmental monitoring excursions, aseptic personnel qualification, aseptic operations, classified areas, utilities, and QC Microbiology.
- Author EM and Utility trending reports at designated frequencies (i.e., quarterly, and annually).
- Creation and Revision of technical documents (SOPs, Risk Assessments, Reports, Protocols, etc.).
- Author impact assessments for moderate level site change controls, as requested.
- Participate in quality risk assessments associated with contamination control program, owned by sterility assurance or stakeholder departments. Assist with facilitation or serve as risk champion for department owned risk assessments.
- Support the Contamination Control Strategy, Quality Initiatives, and Identify continuous improvement opportunities. Support execution of site/team improvement goals and projects related to environmental and contamination control programs.
- Routinely recognize and resolve Quality issues; propose solutions for complex issues and work with management to resolve.
- Ability to collaborate with cross-functional team members on projects related to contamination control program. Build and maintain strong relationships with partner departments.
- Lead meetings and represent department at cross-functional meetings sharing data and knowledge across team.
- Maintain compliance with assigned learning plan.
- Support internal and external inspections as required.
- Perform other tasks as assigned.
Reporting Relationship
This position reports to the Associate Director of Quality Assurance Sterility Assurance at Cell Therapy Manufacturing: Bothell.
Qualifications
- Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy.
- Advanced knowledge and experience with cGMP manufacturing, Quality and Compliance.
- Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
- Ability to interpret data and results, understand problems with few variables and critically assess and provide feedback on proposed solution and required documentation.
- Ability to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles.
- Ability to work in a fast-paced team environment and balance workload based on changing priorities.
- Detail oriented and task focused with ability to meet deadlines and prioritize work.
- Able to work across functional groups and teams to ensure requirements are met.
- Self-motivated and contribute to a positive team environment.
- Confident in making decisions for non-routine and minor issues.
- Curious and ability to think critically to create innovative solutions.
- Proficient computer skills with knowledge of several digital tools like MS Office, Quickbase, Smartsheets, and ability to learn new software applications.
Education/Experience
- Bachelor's Degree in Microbiology, Biology, STEM, or related science and 4+ of relevant cGMP experience, or equivalent combination of education and experience.
- Experience in Quality Control function in a cGMP manufacturing operation.
- Experience in FDA/EMA or similar regulation in biotechnology or cellular therapy field is preferred.
- Demonstrated ability to work cross-functionally to develop and maintain strong business partner relationships.
- Demonstrated experience with electronic systems and databases.
- Demonstrated experience with root cause analysis and risk management tools such as 5-WHY, Human Error Prevention, Fishbone Analysis, FMEA, PrHA, etc.
