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Fresenius Kabi USA · 8 hours ago

QA Project Leader

Melrose Park, IL

Full-time

Onsite

Mid Level

$90K/yr - $110K/yr

3+ years exp

Fresenius Kabi USA is a company focused on maintaining quality systems and compliance in the pharmaceutical industry. The QA Project Leader will manage compliance-related projects, ensuring effective implementation of quality systems and metrics to support GMP compliance and product quality.

Health Care

H1B Sponsor Likely

Responsibilities

Serve as a change agent performing project management duties (PMO)

Manage projects independently while focusing on providing the most impact by coordinating and overseeing projects led by various QA and operations team

Perform PMO duties by tracking progress, ensuring project plans have clear deliverables, deadlines, and responsibilities

Provide progress reports, assist in removing barriers, and escalate issues when additional support is needed

Manage projects that primarily focus on compliance or continuous improvement / simplification category

Key areas of impact in the plant are deviation reduction, improvements in batch right the first time (BRFT) and batch release cycle time (also known as CRT)

Additional areas of impact include reduction of full and partial rejects, yield improvement, complaint reduction, deviation reduction, and CAPAs project management

Perform analysis on quality and manufacturing indicating data and recommend actions for compliance and process improvements

Consolidate quality metrics and reporting in collaboration with respective QA reporting heads

Perform review of root-cause analysis and other problem solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures

Participate in regulatory / FDA inspections and audits by providing information and/or acting as scribe. Expediting / obtaining information required by the inspectors / auditors

Prepares and presents progress reports for senior management

Identify and resolve emerging issues that may impact project or corporate goals

Recognize potential threats to project success and elevate issues to senior management

Develop and implement contingency plans

All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the health, safety, environment, energy, and quality management systems, as per their roles and responsibilities

Qualification

CGMP ComplianceProject ManagementQuality AssuranceRoot-Cause AnalysisCommunication Skills

Required

Bachelor degree in science with a minimum of 3+ years of progressive challenging QA/QC experience in a pharmaceutical or related regulatory industry

Advanced training or experience in cGMP and preferably GLP, legal, and ISO requirements

Benefits

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits to include medical, prescription drug, dental and vision coverage

Life insurance

Disability

Wellness program

Company

Fresenius Kabi USA

Fresenius Kabi is health care company specializing in medical and medical technologies.

Founded in 1996

Lake Zurich, Illinois, USA

1001-5000 employees

http://www.fresenius-kabi.us

H1B Sponsorship

Fresenius Kabi USA 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 (13)

2024 (17)

2023 (17)

2022 (15)

2021 (14)

2020 (22)