Quality Assurance Associate

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

Company 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 about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube.

Job Description

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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html