Quality Assurance Associate: Cleanroom & GMP Specialist

Allergan; Waco, Northern (TX, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

AbbVie is seeking a Quality Associate to support the Quality Function on the shop floor, ensuring conformance to AbbVie Quality System requirements and regulatory standards. You will collaborate with Manufacturing SMEs, complete batch record reviews, and coach colleagues in cleanrooms, contributing to continuous improvement in Operations.

The role requires a Science/QA/Engineering background with 4+ years in a regulated environment and excellent communication skills; shift work is required (B2

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

• 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.

Skills

Quality Assurance

Regulatory compliance

Communication

Education

Associate Degree in Science/QA/Engineering

Job description

AbbVie is seeking a Quality Associate to support the Quality Function on the shop floor, ensuring conformance to AbbVie Quality System requirements and regulatory standards. You will collaborate with Manufacturing SMEs, complete batch record reviews, and coach colleagues in cleanrooms, contributing to continuous improvement in Operations.

The role requires a Science/QA/Engineering background with 4+ years in a regulated environment and excellent communication skills; shift work is required (B2