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
\
**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