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CAPA Specialist II
Ref No.: 17-15578
Location: San Diego, California
Job Title: CAPA Specialist II
Location: San Diego, CA
Duration: 1 Year
PART TIME- working 8-5 on Tuesdays and Thursday, potentially Monday, Wednesday, Fridays on 1/2 days. Approximately 20 hours/week

Filling in for someone who is going to school
Perfect Opportunity for someone who is in school and looking for additional work/experience!

The CAPA Specialist II is responsible for ensuring the CAPA system is being managed effectively as part of the CAPA Administration group. They must work well with others in the organization to ensure Quality System processes are compliant to internal and external requirements.

Tasks and responsibilities:

• Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.
• Support and guide the CAPA Board and Users regarding the CAPA process, CAPA record content, and CAPA software
• Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training
• Ensure implementation and effectiveness verification of CAPA and participate in remediation of legacy CAPA files.
• Track CAPA process metrics to support improvement activities and management review.
• Ensure that CAPA records are complete and they contain accurate links and references to other Quality processes such as Change Management, Non-Conformance, and Complaint Handling.
• Participate in problem solving efforts to resolve recurring and new quality issues in order to ensure production of safe and effective medical devices. Apply problem solving techniques to problems of moderate scope and complexity.
• Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation and effectiveness of Alere Quality Management System per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Perform other duties & projects as assigned.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

Preferred educational background:
Bachelor's degree in a related technical field is preferred but not required.

Preferred experiential background:
• Must have at least 2 to 4 years' experience working in a professional environment where compliance was of vital importance.
• Knowledge of the QSR or ISO 13485 is a plus.
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
• Knowledge of MS Office.
• Excellent organization skills – must be able to manage a large number of simultaneous projects
• Attention to detail – must have precision in their work, especially as it relates to understanding and documenting complex quality issues
• Excellent writing skills – must be able to summarize complex issues in a clear, succinct, and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.
• Effective interpersonal skills – Work with peers throughout the organization and be effective in engaging resources throughout the organization
• Excellent critical analytical skills – ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue

All listed tasks and responsibilities are deemed as essential functions to this position; however, reasonable accommodations will be made if at all possible under business conditions.