Compliance Engineer
3 weeks ago
- Industry: Pharmaceutical industry or medical device experience required
- Location: Onsite - Round Lake, Illinois (60073)
- Type: Contract - (NO C2C OR THIRD PARTY)
- 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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