Quality Engineer
at Katalyst Healthcares Life Sciences
Round Lake, IL 60073, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 28 Jul, 2024 | Not Specified | 30 Apr, 2024 | 5 year(s) or above | Lean Principles,Auditing,Compliance Management Systems,Regulatory Guidelines,Compliance Management,Presentation Skills,Pharmaceutical Industry,Due Diligence,Ema | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
- 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.
Requirements:
- 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.
- 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.
Responsibilities:
- 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
REQUIREMENT SUMMARY
Min:5.0Max:10.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
BSc
Engineering
Proficient
1
Round Lake, IL 60073, USA