Senior Compliance Engineer

2 weeks ago


Round Lake, United States Kelly Science, Engineering, Technology & Telecom Full time

Location: Onsite - Round Lake, Illinois (60073)

Type: Contract - (NO C2C OR THIRD PARTY ACCEPTED)

Duration: 6+ months - Opportunity for contract extension long term

Pay Rate – Negotiable depending on DIRECT-related experience

Work Authorization - Must be able to work in the U.S. with approved authorization status as a citizen or lawful permanent resident of the United States. Visa Status is not allowed for this role as current or future sponsorship is unavailable.

This role is NOT a validation engineering role


  • Candidates cannot be allergic to Penicillin or Cephalosporins.


Preferred:

  • Project management experience
  • Experience with due diligence, auditing, compliance management, or regulatory experience
  • Hands-on experience in drug product aseptic manufacturing operations



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.



RESPONSIBILITIES:

  • Work with internal auditors to develop programs to ensure continued compliance with policies and regulations.
  • 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.
  • Evaluate quality data and determine strategies, actions, and initiatives to drive improvements in the facility


Qualifications:

  • Experience with pharmaceutical and/or device quality and compliance management systems
  • Knowledge of cGMP and global regulatory guidelines such as EMA, FDA, and other health agencies.
  • Knowledge of Six Sigma methodology and LEAN principles.



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.



Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.



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