AbbVie · 14 hours ago
Senior Quality Engineer, Medical Device & Combination Product Quality Systems
North Chicago, IL
Full-time
Onsite
Senior Level
$78K/yr - $141K/yr
6+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Senior Product Quality Assurance Analyst is responsible for overseeing Quality Assurance activities related to Third Party Manufacturing plants, ensuring compliance with good manufacturing practices and regulatory requirements.
BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
Responsibilities
Maintains an effective liaison and cooperative relationship with other AbbVie Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites
Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by AbbVie QA Operations
Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site
Review and approve manufacturing directions to the production floor
Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation
Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented
Perform annual Product Quality Review according to AbbVie global procedure to comply with regulatory requirements
Participates in Trend Review Board to monitor process track and trending
Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites
Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation
Qualification
Required
Bachelor's degree preferably in Engineering or Science
Six years of experience within the Pharmaceutical operations, preferably Biologic manufacturing process
Knowledge of GMP regulations and standards affecting pharmaceutical products
Comprehensive knowledge and application of business and quality concepts
Strong analytical skills and attention to detail
Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences
Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization
Preferred
Change plan, Exception Reports, SAP and LRMS experience is highly preferred
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Company
AbbVie
AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.
10001+ employees
H1B Sponsorship
AbbVie has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)
Funding
Current Stage
Public CompanyTotal Funding
$15B2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO
Leadership Team
Robert Michael
Chairman of the Board and Chief Executive Officer
Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
Recent News
Labiotech UG
2026-02-07
Pharma Letter
2026-02-06
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