Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Abbott Rapid Diagnostics is part of Abbott's Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of QA Specialist II is within our Cardiometabolic business unit located at the Biologics Center of Excellence (ARDx Carlsbad) in Carlsbad, California. This role is responsible for ensuring that the NC/CAPA system is being managed effectively as part of the NC/CAPA Administration group. This role is also responsible for QA Batch Record Reviews for in-process and finished products. 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:

NC/CAPA Administration - Responsible for ensuring NC/CAPA files and actions are being properly administered:

• Provide site administration of the NC/CAPA files and actions and support process owners in completing NCs & CAPA actions and related business items.
• Support 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 NC/CAPA procedures, NC/CAPA software, and NC/CAPA training.
• Provide support to NC owners on performing proper non-conformance documentation.
• Provide support to CAPA owners on use of Quality tools for use in root cause analysis.
• Perform historical searches to support risk assessments, NC/CAPA investigations, and Validations.
• Use critical reasoning skills to participate in, conduct, and review investigations into quality issues.
• Employ program management skills to ensure implementation of adequate controls and corrective actions to prevent recurrence of nonconformances. Develop and apply statistical methods for verification of CAPA effectiveness.
• Participated and support the effectiveness verification of CAPA.
• Track NC/CAPA process metrics to support improvement activities and management review.
• Ensure that NC/CAPA records are complete and they contain accurate links and references to other Quality processes.
• Assist with managing the archival and handling of scanned CAPA records.

Batch Record Review (QA BRR):

• Ensure that received Batch Records are reviewed in a timely fashion.
• Ensure that received Batch Records are reviewed fully and accurately, in accordance with documented procedures.
• Responsible for the creation of Certificate of Analysis Documents for finished Biologics Component Reagents lots.
• Responsible for driving continuous collaboration with Operations and R&D on documentation error correction.

General Responsibilities:

• Responsible for the creation of Quality Metrics to support OPEX and QA Management Reviews
• Participate in problem solving efforts to resolve recurring and new quality issues. 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.
• Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO and other regulatory agencies.
• Provide ongoing support to Quality management during internal & external audits.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
• 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 | EDUCATION/EXPERIENCE:

• Bachelor's degree, or the equivalent 2-4 years' experience in a GMP/ISO or an FDA controlled environment.

PREFERRED QUALIFICATIONS:

Preferred educational background:

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

Preferred experiential background:

• Two to four 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 several 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.
• Leverages enterprise-wide tools and technologies.
• Comfortable with ambiguity. Implements change when needed.
• Avoids getting stuck in a "one right way" approach - remains open minded to new ideas.
• Promptly and effectively handles issues and problems.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please contact your local HR department.

JOB FAMILY:
Operations Quality

DIVISION:
ARDx Abbott Rapid Diagnostics

LOCATION:
United States > Carlsbad : IBIS BioSciences

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf