Aseptic MQA

PowerToFly; Kansas City (MO); On-site; USD 85,000 - 110,000; Full time

Job summary

AbbVie seeks a Quality professional to provide real-time shop floor oversight of aseptic operations on site, driving continuous improvement and ensuring adherence to site procedures. The role requires strong GMP knowledge, regulatory understanding, and excellent communication to mentor shift teams and ensure high performance across manufacturing and sampling activities.

The candidate will review batch records, support training, and lead aseptic investigations, contributing to the site

Qualifications

• Bachelor-level degree in a science, quality, or engineering discipline.
• 3+ years in a GMP environment with aseptic manufacturing support.
• Strong knowledge of regulatory requirements.
• Excellent communication skills are essential.

Responsibilities

• Provide real-time shop floor oversight to aseptic operations on site.
• Drive continuous improvement in aseptic operations and maintain high performance standards.
• Mentor and coach shift teams; ensure procedures are followed and batch records are reviewed.
• Lead investigations and participate in routine leadership GEMBAs for manufacturing and lab areas.

Skills

Excellent communication

GMP environment experience

Aseptic manufacturing knowledge

Education

Third Level Degree in Science/Quality/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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

As amember of the Quality function, provides real-time shop floor oversight to Aseptic operations, both manufacturing, samplingand testing. Partners with Site colleagues to create an environment of the highestperformancestandards of Aseptic operations. Drives continuous improvement in Aseptic Operations on site. This role requires shift work.

Responsibilitiesspecific to Aseptic Manufacturing(in additionto other duties as assigned):

• Act as site Subject Matter Expert for AsepticOperations(Manufacturing, samplingand associated testing).

• Ensures Aseptic operations are carried out as per Site Procedures.

• Continuously observes the Aseptic technique andbehaviorof the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drives a culture of Speak-Up.

• Drives all aspects of Aseptic Performance of the shift team through observation andfeedback.

• Drives all aspects of Aseptic performance during sampling and testing.

• Partners with Aseptic Mentors and Shift Supervisors to drive performance of the shift team.

• Completes real-time review of Batch Record documentation.

• Supports training activities and actively coaches and mentors colleagues who work in Cleanrooms.

• Provides Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, AsepticSet-up, sampling, EM plate handling, sample testingand Interventions.

• Participates and provides leadership to the Site Aseptic team, highlighting and leading introduction of continuous improvement in Aseptic procedures.

• Provides input and guidance on changes related to Aseptic Manufacturing, samplingandassociated testing.

• Drives a high-performance Aseptic culture across the site.

• Actively leads and supports investigations.

• Reviews and Audits Batch Records real-time

• Reviews and Audits Manufacturing and Testing logs as required.

• Completion of Line Clearance activities

• Participate 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.

Qualifications

• Third Level Degree in a Science, Quality or Engineering discipline.

• 3+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing

• Strong knowledge of Regulatory Requirements

• Excellent communication skills

Additional Information

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, visithttps://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

What AbbVie Has to Offer

Our work can—and does—have a tangible, lasting impact on millions of people. But it’s not just the results that matter. How we achieve them matters, too. Leading with purpose, we work to build a more sustainable future for generations to come. We do that by putting our expertise, resources and talent to work to make a real difference for patients, communities and our world.