Quality Assurance Associate

Regulatory Jobs; Waco (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Job summary

AbbVie in Texas seeks a Quality Associate to support the Quality Function on the shop floor. You will provide real-time oversight to operations, ensuring conformance with AbbVie Quality System requirements and regulatory standards.

You will partner with Manufacturing SMEs and Shift Supervisors, review batch records, support investigations, and coach colleagues in cleanrooms as part of continuous improvement.

Qualifications

• Associate Degree in a Science, Quality or Engineering discipline.
• 4+ years of experience in a pharmaceutical and/or medical device regulated environment
• Knowledge of Regulatory Requirements
• Excellent communication skills

Responsibilities

• Provide real-time shop floor oversight of quality-related activities.
• Ensure product conformance with AbbVie Quality System and regulatory requirements.
• Collaborate with Manufacturing SMEs and Shift Supervisors to drive shift performance.
• Review Batch Records and Manufacturing logs.
• Support quality investigations and training activities.
• Coach colleagues in Cleanrooms and participate in GEMBAs.
• Contribute to Site Contamination Control Strategy and EM data trend assessments.

Skills

Quality assurance

Quality control

Regulatory requirements

Communication skills

Education

Associate Degree in Science/Quality/Engineering

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information, visit www.abbvie.com.

Role Overview

The Quality Associate supports the Quality Function that they are responsible for within Operations. As a member of the Quality function, provides real-time shop floor oversight to the assigned operations. Partners with Site colleagues to create an environment of the highest performance standards for the operations. Drives continuous improvement in the Operations on site.

Responsibilities

• Responsible for various aspects of quality assurance and quality control related to their functional area.
• Ensures that product within the plant is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
• Partners with Manufacturing SMEs and Shift Supervisors to drive performance of the shift team.
• Completes real-time review of Batch Record documentation and Manufacturing logs.
• Actively supports Quality investigations.
• Completing training activities as required and actively coaching and mentoring colleagues who work in Cleanrooms.
• Participates in routine leadership GEMBAs of Manufacturing and Laboratory areas.
• Provides key input to the development and maintenance of the Site Contamination Control Strategy.
• Provides key input to the assessment of EM data and trends.
• Serve as an expert and as a consultant in clean room good practices and behaviors.

Qualifications

• Associate Degree in a Science, Quality or Engineering discipline.
• 4+ years of experience in a pharmaceutical and/or medical device regulated environment
• Knowledge of Regulatory Requirements
• Excellent communication skills

B2 Shift: 5:45pm-6am, Wednesday-Friday and every other Saturday

Compensation & Benefits

• The compensation range is the range of possible base pay the Company believes in good faith it will pay for this role at the time of posting based on the job grade. Individual compensation depends on many factors including geographic location.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. Applicants seeking a reasonable accommodation: https://www.abbvie.com/join-us/reasonable-accommodations.html