Quality Assurance Associate

Quality Associate

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 Abb Vie 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 Clean rooms.
• 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

Additional Information:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.
  
  This range may be modified in the future.
• 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.

Abb Vie 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.