QA Associate II

Abbott • Pomona, CA

12d • Onsite

About The Position

Abbott Rapid Diagnostics is part of Abbott

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 115,000 colleagues serve people in more than 160 countries. 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.

Requirements

• 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

Nice To Haves

• Bachelor’s Degree
• Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic
• Knowledge of Quality System Regulations

Responsibilities

• 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 company’s 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 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.

Benefits

• 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 bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED