This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/jobs/11860699

Date Posted:04/26/2024

Hiring Organization:Rose International

Position Number:462987

Job Title:Compliance Engineer

Job Location:Round Lake, IL, USA, 60073

Work Model:Onsite

Employment Type:Temporary

Estimated Duration (In months):6

Min Hourly Rate(\$):55.00

Max Hourly Rate(\$):60.00

Must Have Skills/Attributes:Audit, Compliance, Medical device, Pharmaceutical

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**Only those lawfully authorized to work in the designated country associated with the position will be considered.**

**Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a clients business needs and requirements.**

\ Job ID: BXTRJP00025076\ 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.\ \ Education and Experience\ At least 5 years of directly related experience within the pharmaceutical industry or medical device experience\ BS in Science or Engineering. Advanced degree a plus.\ Project management experience, preferred.\ Previous experience with due diligence, auditing, compliance management or regulatory experience is a plus.\ \ Qualifications:\ 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.\ \ ESSENTIAL DUTIES AND RESPONSIBILITIES:\ Other duties may be assigned:\ 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.\ \ Benefits:

For information and details on employment benefits offered with this position, please visithere{target="blank" rel="noopener"}. Should you have an y questions/concerns, please contact our HR Department via our securewebsite{target="blank" rel="noopener"}.

California Pay Equity:\ For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations\' websitehere{target="_blank" rel="noopener"}.

Rose International is an Equal Opportunity Employer. All qu