CAPA Process Analyst II

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Job description

The position of CAPA Specialist I is within our IDDM business unit located at San

Diego, CA. This role 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.

This job description will be reviewed periodically and is subject to change by

management.

RESPONSIBILITIES:

CAPA Administration - Responsible for ensuring CAPA system is being managed effectively.

• Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.

• Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.

• Support the development, implementation and continuous improvement 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.

• 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.

• Manage the archival and handling of scanned CAPA records.

• Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.

• Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.

• Provide ongoing support to Quality management during external audits.

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

• 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; build productive internal/external

working relationships

• Carries out duties in compliance with established business policies

JOB DESCRIPTION

• Other duties as assigned, according to the changing needs of the business

SUPERVISORY RESPONSIBILITIES

• N/A

MINIMUM QUALIFICATIONS EDUCATION/EXPERIENCE:

• Bachelor's degree, or the equivalent 1-2 years' experience in a FDA controlled environment.

PREFERRED QUALIFICATIONS:

Preferred educational background:

Bachelor's degree in a related technical field is preferred but not required.

Preferred experiential background:

• One to two 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

COMPETENCIES:

• Acts ethically and takes accountability for achieving outcomes.

• Comfortable with ambiguity. Implements change when needed.

• Promptly and effectively handles issues and problems.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."

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