JOB SUMMARY
This position requires a versatile skill-set that enables working with a wide range of responsibilities, ranging from conducting investigations, performing audits and evaluating quality systems to serving as a backup for CAPA administration. Facilitates company-wide improvements in areas such as training, supplier evaluation, and analysis of data.
ESSENTIAL FUNCTIONS
1. Ensures effective implementation of components of CAPA process e.g. non-conformances, equipment out of tolerance findings, etc.
2. Leads effective implementation of Cleaning Audit Process
3. Evaluates the effectiveness and efficiency of regulated processes throughout the organization and makes recommendations for improvement.
4. Leads execution of Irradiation Dose Audit Process
5. Tracks the results of Irradiation Dose Audits and evaluates the requirement to escalate the need of execution of reaction plan
6. Evaluates and ensures compliance of purchased material specifications per company policies
7. Facilitates development/implementation of systems and quality/performance indicators.
8. Assists in preparation and follow up for Management Review meetings.
9. Creates and revises Standard Operating Procedures consistent with GMP/GTP, AATB, and ISO requirements.
10. Utilizes project management skills and participates on projects teams as directed.
11. Serves as a backup for CAPA administration.
12. Reviews and conducts complaint investigations to ensure thorough root cause analysis and appropriate corrective actions.
13. Verifies effectiveness of corrective actions.
14. Reviews reports and assists with follow up of findings from ISO, FDA, AATB, and state audits.
15. Participates on project teams as assigned.
16. Assists organization in ensuring compliance with all applicable regulations and standards.
OTHER FUNCTIONS
1. Performs any other duties as assigned.
2. Participates in Divisional and Departmental activities including routine meetings.
3. Complies with, and ensures departmental compliance with Quality Systems program.
4. Complies with Corporate Compliance Program.
5. Conducts all activities and behaviors in accordance with Guiding Principles.
WORKING CONDITIONS
Normal office environment
EQUIPMENT/MACHINERY USED
Office equipment including computer, fax, photocopier, and telephone.
PHYSICAL REQUIREMENTS
Sitting, manual dexterity, visual acuity, reading, bending, lifting up to 50 lbs., and driving.
MINIMUM REQUIREMENTS
1. Baccalaureate degree required.
2. Knowledge of Quality Systems Regulations, Good Tissue Banking Practices and ISO 13485 standards preferred.
3. AATB Certified Tissue Bank Specialist preferred.
4. Statistics experience, education or the ability to learn.
5. Demonstrated verbal, written, and presentation skills.
6. Valid State driver’s license.
SEND RESUMES:
Julie Campbell Buck I Regional IT Talent Solutions I Greater Seattle Area
Julie.CampbellBuck@kellyit.com I www.kellyit.com I LinkedIn
W: 425-653-1751 I M: 425-328-4319 I F: 425-747-4649
