Principal Engineer

Adecco Healthcare & Life Sciences is hiring a contract Compliance Engineer for our Medical partner in Round Lake, IL.

The anticipated wage for this position is between $59 and $61. Hourly wage may depend upon experience, education, geographic location, and other factors.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria

Compliance Engineer Four-Month Contract

Candidates cannot be allergic to Penicillin or Cephalosporins.

Description

JOB SUMMARY: 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.

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.

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.

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.

Pay Details: $59.00 to $61.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.