Compliance Specialist- Clinical Trails
- Recruiter
- Confidential
- Location
- York
- Salary
- Competitive
- Posted
- 02 Jun 2022
- Closes
- 30 Jun 2022
- Sectors
- Health, Nursing & Social Care
- Contract Type
- Permanent
- Hours
- Full Time
This role provides leadership and direction to ACM Global Laboratories' quality processes througout the business. Leads the quality performance process to drive quality outcomes across the organization. Partners with internal/external key stakeholders to monitor, report and continually improve the quality performance process. Support corrective action/preventative action (CAPA), quality issues resolution and continuous improvement.
ATTRIBUTES
* Bachelor's Degree required; preferably in Engineering, Business.
* Minimum of 3 years of continuous improvement experience required; preferably in an operational, laboratory, or operations quality environment.
* Minimum of 1 year of experience in corrective action/preventative action (CAPA) and quality issue (QI) resolution required.
* Experience in a regulated environment such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) or International Organization for Standardization (ISO), preferred.
RESPONSIBILITIES
* Quality Support. Lead the overall quality performance process and drive quality process outcomes. Develop, monitor and refine quality performance process; partner with key stakeholders to track and trend Key Performance Indicators. Leverage and refine tools to elevate internal reporting of overall quality performance. Study existing operations and processes to identify opportunities to drive out waste and improve profitability.
* Process Improvement. Drive containment, root cause determination, and short-term and long-term corrective action, and preventive action ongoing basis. Assist in developing, implementing, and coaching operations personnel on root cause identification and appropriate closed-loop corrective and preventive action and in the use of quality improvement tools such as PDCA, Six Sigma, Problem Solving, Quality Tools, etc. Facilitate Kaizen events using a range of Lean tools.
* Training & Support. Deliver relevant training and coaching, to ensure employees are appropriately educated throughout the business. Responsible for reporting overall quality performance to Executive Leadership team and key stakeholders. Communicate critical issues in a timely manner
CERTIFICATION
* Lean Champion Certification, Lean Six Sigma Green Belt Certification, Lean Six Sigma Black Belt Certification and/or similar training/certification preferred
ATTRIBUTES
* Bachelor's Degree required; preferably in Engineering, Business.
* Minimum of 3 years of continuous improvement experience required; preferably in an operational, laboratory, or operations quality environment.
* Minimum of 1 year of experience in corrective action/preventative action (CAPA) and quality issue (QI) resolution required.
* Experience in a regulated environment such as Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) or International Organization for Standardization (ISO), preferred.
RESPONSIBILITIES
* Quality Support. Lead the overall quality performance process and drive quality process outcomes. Develop, monitor and refine quality performance process; partner with key stakeholders to track and trend Key Performance Indicators. Leverage and refine tools to elevate internal reporting of overall quality performance. Study existing operations and processes to identify opportunities to drive out waste and improve profitability.
* Process Improvement. Drive containment, root cause determination, and short-term and long-term corrective action, and preventive action ongoing basis. Assist in developing, implementing, and coaching operations personnel on root cause identification and appropriate closed-loop corrective and preventive action and in the use of quality improvement tools such as PDCA, Six Sigma, Problem Solving, Quality Tools, etc. Facilitate Kaizen events using a range of Lean tools.
* Training & Support. Deliver relevant training and coaching, to ensure employees are appropriately educated throughout the business. Responsible for reporting overall quality performance to Executive Leadership team and key stakeholders. Communicate critical issues in a timely manner
CERTIFICATION
* Lean Champion Certification, Lean Six Sigma Green Belt Certification, Lean Six Sigma Black Belt Certification and/or similar training/certification preferred