QA Associate II

JOB DESCRIPTION:

QA Associate II

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

• An excellent retirement savings plan with high employer contribution.

• Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.

The Opportunity

Abbott Rapid Diagnostics is part of Abbotts 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 Quality Assurance Associate II is within our Toxicology business unit. Under the supervision of the Supervisor/Manager the scope of this position is responsible for carrying out the daily operations in the batch record department.

What Youll Work On

• Demonstrated ability to carry out assignments in a timely accurate manner and accomplishing tasks as required with little or no supervision.

• Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast-paced environment.

• Participate in Quality processes with a focus on record administration batch record review and Certificate of Analysis / Certificate of Conformance creation for material lot release. Collaborates with submitters to troubleshoot any records issues.

• Work with groups within the organization to get corrections and clarifications to Device History Records.

• Receives reviews and classifies incoming quality systems records and supporting materials such as Validations Batch Records Lab Notebooks etc.

• May prepare labeling for all finished product and perform labeling of product.

• Creates files labels and barcodes incoming records and prepares them for storage based on the companys record retention policy.

• Manages verbal and written requests for records. Locates retrieve deliver and follow up on checked out records as requested.

• Reviews incoming records for good documentation practices and partners with process owners to ensure documentation errors are corrected prior to scanning.

• Utilize database to perform transactions and verify product information.

• Generate and/or review Certificate of Conformance / Certificates of Analysis for Final Product.

• Filing of records.

• Works on assignments that are moderately complex in nature where judgment is required in resolving problems.

• Must be well versed on governing processes for records and be able to identify deficiencies in incoming and outgoing records.

• Knowledgeable of federal and other regulations e.g. QSRs ISO 13485 CMDR etc.

• 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 companys 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.

Required Qualifications

• High School Diploma or GED

• 1-3 years of related experience

• Experience with MS Office

• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

• Strong communication problem solving and motivational skills

• Must be detail-orientated self-motivated and available for flexible scheduling

Preferred Qualifications

• Bachelors Degree

• Working knowledge of Quality Assurance in a medical device manufacturing environment preferably in-vitro diagnostic

• Knowledge of Quality System Regulations

Competencies:

• High level of attention to detail

• Teamwork

• Communication

• Strong organizational skills

• Initiative

• Adaptability

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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