• Job Description

  Req#: 23-05080
  
  
  Job Description
  
  CAPA Specialist
  • Contract Duration 12 Months
  • Pay rate up to $46/hr
  
  Job Description:
  • The position of CAPA Specialist I is within our business unit located in 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 with internal and external requirements.
  • This job description will be reviewed periodically and is subject to change by management.
  
  Job Responsibilities:
  • CAPA Administration – Responsible for ensuring the 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.
  • The CAPA Specialist supports 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
  • Other duties as assigned, according to the changing needs of the business
  
  Minimum Qualifications:
  • Bachelor's degree, or the equivalent of 1-2 years experience in an FDA-controlled environment.
  
  Preferred Qualifications:
  • Bachelor's degree in a related technical field is preferred but not required.
  • 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 – the ability to find the root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue
  
  Job Competencies:
  • Acts ethically and takes accountability for achieving outcomes.
  • Comfortable with ambiguity. Implements change when needed.
  • Promptly and effectively handles issues and problems.
  
  Benefits:
  • Medical, Vision, and Dental Insurance Plans
  • 401k Retirement Fund
  
  About the Company:
  • Our client is a globally diversified healthcare company with a central purpose to help people live their healthiest possible lives. They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies. They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.
  • If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees that have written positive reviews on Glassdoor and Indeed.
  
  #GTTUS2

• About the company

  Global Technical Talent specializes in recruiting and pre-qualifying senior level IT professionals for clients' immediate long- and short-term contract needs, contract to hire and direct hire positions. Because we work exclusively with high level I...

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