10 Compliance Engineer Jobs in Round Lake, IL
Stefanini Group is Hiring a Compliance Engineer Near Round Lake, IL
Stefanini Group is hiring!Stefanini is looking for Compliance Engineer in Round Lake, ILFor quick Apply, please reach out to Nitin Kumar Chandila - call: 248-263-3906/ email: NitinKumar.Chandila@stefanini.comWork Hours: M-F (40 hours)
Work Location: Round Lake, IL
Shift: 1st Shift
Schedules, plans, and coordinates compliance audits and quality systems assessments ensuring compliance with corporate and regulatory provisions of the Quality System. Conducts internal audits and compliance gap analysis using the applicable quality manuals, global and/or local procedures, applicable country regulations, directives, standards, inspection guidelines and compendia as requirements. Supports management during external inspections and participates in the preparation, coordination, and management of external inspections as required.
Responsibilities:
- Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
- Support internal audit process ensuring compliance with all applicable regulations and standards.
- Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility. Work with cross functional teams on implementation.
- Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness.
- Evaluates corrective and preventive action responses to the audit findings for adequacy, including root cause determination and timeliness. Escalates issues to management as appropriate. Tracks and reports on commitment status through closure.
- Manages the audit file through the entire process to closure. Prepares summary reports depicting results and trends for management review purposes.
- Performs follow-up audits, when applicable, to confirm corrective and preventive action is effective.
- Candidates cannot be allergic to Penicillin or Cephalosporins.
Details:
- BS in Science or Engineering. Advanced degree a plus.
- At least 5 years of directly related experience within the pharmaceutical industry or medical device experience
- Project management experience preferred.
- Previous experience with due diligence, auditing, compliance management or regulatory experience is a plus.
- Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
- Knowledge of Six Sigma methodology and LEAN principles.
- Effective communicator at all levels; excellent written, oral, and interpersonal communication and presentation skills
- Experience with pharmaceutical and/or device quality and compliance management systems, desired.
- Hands-on experience in drug product aseptic manufacturing operations is desired, but not required.
About Stefanini GroupThe Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
Job Summary
Contractor
IT Outsourcing & Consulting
$77k-94k (estimate)
06/01/2024
07/19/2024
stefanini.com
FORT LAUDERDALE, FL
15,000 - 50,000
2005
ANTONIO C MOREIRA
$10M - $50M
IT Outsourcing & Consulting
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About Stefanini Group
We are a global company with 30 years of experience in the market, offering a robust selection of services such as automation, cloud, Internet of Things (IoT) and user experience (UX). Today, we provide a broad portfolio of solutions, combining innovative consulting, marketing, mobility, personalized campaigns and artificial intelligence services with traditional solutions such as service desk, field service, and outsourcing (BPO). We maintain our excellence by investing in technological innovations, the best partnerships, acquisitions of companies worldwide, and the hiring of highly trained p...rofessionals. We believe technology can revolutionize a company and innovation is essential to foster development and competitiveness. We also value new ideas and the power of an open mind, so we recognize every talent is essential to the quality of our projects and especially to our progress.
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The job skills required for Compliance Engineer include Commitment, Initiative, Consulting, Project Management, Continuous Improvement, Presentation, etc. Having related job skills and expertise will give you an advantage when applying to be a Compliance Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Compliance Engineer. Select any job title you are interested in and start to search job requirements.
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