Quality Systems Specialist
Help save lives every day! Bloodworks is hiring for a Quality Systems Specialist. In this position, you will manage and monitor quality systems within Bloodworks, including maintaining a current working knowledge of applicable regulations and standards, reviewing and approving standard operating procedures, and reviewing and approving validation plans and validations. You will also be responsible for coordinating systems audits and audit follow-up, facilitating external inspections, monitoring errors and customer service issues, and conducting quality systems training for staff.
ADDITIONAL PRINCIPAL RESPONSIBILITIES:
- Advise Bloodworks departments on quality assurance and regulatory requirements.
- Assure that Bloodworks policies, processes, and procedures are developed in compliance with requirements and standards of regulatory and professional agencies.
- Analyze Quality Control and Proficiency Testing programs to assure participation in appropriate programs for compliance with regulations.
- Conduct error investigations and monitor investigation follow-up.
- Facilitate timely external reporting of errors and deviations as required.
- Host inspections by regulatory agencies and other external auditors.
- Coordinate and prepare reports in response to findings by external agencies.
- Review SOPs for compliance with regulations, standards, and other requirements.
- Assure that product labeling is in compliance with regulations, standards, and SOPs.
- Assess the frequency, scope, and magnitude of validation testing based on the criticality of the production facility, production equipment, software program, and/or production process.
- Advise and train department staff in the development of user validation protocols.
- Develop and provide Bloodworks training in compliance and safety.
- Prepare status reports on goals and objectives, assigned projects and duties, and organizational compliance status.
- Other duties as required.
EDUCATION & EXPERIENCE:
- Bachelor’s Degree in a related field, or equivalent education and experience.
- Minimum 2 years of Quality Assurance experience in regulated environment.
SPECIFIC JOB SKILLS:
- Knowledge of current Good Manufacturing Practices for Biologics, Devices, Drugs, and Tissues, CLIA, WMTS, OSHA/WISHA, and other applicable regulations.
- Demonstrated interpersonal skills in problem resolution in a team environment.
- Demonstrated negotiation and project management skills.
- Seattle, WA, USA