Senior QA Specialist (Grand Rapids, MI)

Posted 21 Days Ago
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Grand Rapids, MI, USA
In-Office
Senior level
Healthtech • Pharmaceutical
The Role
The QA Senior Specialist ensures quality assurance for pharmaceutical products, managing QA activities, leading projects, and supporting regulatory inspections.
Summary Generated by Built In
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, X and YouTube.

Job Description

The QA Senior Specialist is responsible for providing quality assurance support for the pharmaceutical plant. This position will ensure that all product, process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.

  • Develop plans, coordinates and drives for execution Quality projects across multiple site QA areas.
  • Coordinate with site QA planners to achieve project deliverables.
  • Coordinate with centralized function the deployment of global Pharma 3 initiatives.
  • Analyze, manage and maintain data for cycle times, touch times, and tasks/process lists to optimize QA processes performance.
  • Drive for development, improvement and maintenance of site QA planning and scheduling activities.
  • Assure QA areas under scope of the project implement and maintain visual management tools to monitor key QA processes.
  • Analyze and report metrics for planned and unplanned activities for key QA processes. Anticipates and identifies areas of risk and mitigates risks through early risk assessments and implementation of fallback / mitigation strategies.
  • Lead development of the Project Charter and documents the requirements that satisfy the stakeholders’ needs and expectations. Establish project objectives and criteria for evaluating project results and activities of the project team.
  • Support Regulatory inspections for new market introduction.
  • Lead and or coordinate Compliance and Performance improvement projects. Provide status to site management of the assigned projects.
    - Maintains an effective liaison and cooperative relationship with Quality areas from Third Party Contractors (TPC)

 

*This position will be based in Grand Rapids at a third-party manufacturing facility*

 

 

Qualifications

  • Bachelor’s Degree in Business Administration, Sciences or Engineering.
  • Six (6) years of experience in Quality area position, with hands on experience in the following areas: Project Management, Scheduling and Inventory Control.
  • The incumbent must have hands-on experience in Excel, Word, Power Point, etc.
  • Knowledge of statistics is desirable.
  • Must be familiar with the Good Manufacturing Practices and Good Laboratory Practices

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, 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

Skills Required

  • Bachelor's Degree in Business Administration, Sciences or Engineering
  • Six (6) years of experience in Quality area position, with hands on experience in Project Management, Scheduling and Inventory Control
  • Must have hands-on experience in Excel, Word, Power Point
  • Familiar with Good Manufacturing Practices and Good Laboratory Practices

AbbVie Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.

  • Retirement Support 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
  • Parental & Family Support Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
  • Healthcare Strength Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.

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The Company
HQ: Chicago, IL
50,000 Employees
Year Founded: 2013

What We Do

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

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