CAPA Investigator Owner Job at Planet Group, Belvidere, IL

VFFJRHcyTkM5cGdkMGZabXYxVjlhNjUvdGc9PQ==
  • Planet Group
  • Belvidere, IL

Job Description


Target Pay Rate: 40-53.33/hr **salary will be commensurate with experience 

Description:

Essential Duties and Responsibilities: 1. Perform non-conformance (NCR) investigations within the Track Wise 8 Management System. 2. Execute implementation of CAPAs associated with NCR investigations. 3. Maintains a high level of expertise in current regulatory requirements and serve as a plant resource for compliance to these requirements. Maintains audit ready status for assigned areas and assists other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and corporate quality requirements. 4. Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.

Qualifications:

1. Candidate must not be allergic to Penicillins or Cephalosporins 2. Understanding of the products intended use and manufacturing process 3. Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures. 4. Strong problem solving and analytical skills. 5. Consultation and facilitation skills. 6. Understanding of statistics in support of fact based decision making. 7. Excellent written/verbal communication and organizational skills 8. Ability to make independent decisions with minimum oversight 9. Customer sensitivity / acumen and ability to interact with all levels of management. 10. Experienced user of TrackWise preferred. 11. Working knowledge of FDA Regulations and International Regulatory requirements. 12. Understanding of risk management tools. 13. Available to work during off-shift or weekends as appropriate to support investigations and training

Education and/or Experience:
  • BS/BA (4 years of university level education) in science, engineering or related field.
  • 2-4 years relevant work experience in cGMP related industry or in a clinical setting.
  • Greenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plus.

Job Tags

Contract work, Work experience placement, Local area, Shift work,

Similar Jobs

Denham Corporation

Tax Staff Accountant Job at Denham Corporation

DescriptionAre you ready to work in a friendly environment doing what you love? Our client is seeking a Staff Accountant to process day-to-day bookkeeping functions and prepare tax return for their clients. If you have your CPA certificate or are an EA, its even better. There... 

UnitedHealth Group

Healthcare Economics Consultant or Hospital Claims Data Analyst - Remote Job at UnitedHealth Group

 ...skilled nursing facilities, ambulatory surgery centers). The HCE consultant will perform complex analysis using SQL and Excel to help...  ...Platform will also be helpful.You'll enjoy the flexibility to work remotely * from anywhere within the U.S. as you take on some tough... 

All My Sons Moving & Storage

CDL DRIVERS (Class B) Job at All My Sons Moving & Storage

 ...Hiring CDL Drivers Daily! **Once you APPLY, you will receive a text to start the Hiring Process** Join the Winning Team! Come join...  ...REQUIREMENTS AND JOB DUTIES Drivers: 19+ years of age Class B CDL or above Drivers are required to move furniture daily... 

Beth Israel Lahey Health

Assistant Nurse Manager Job at Beth Israel Lahey Health

 ...growing BILH team, you're not just taking a job, you're making a difference in people's lives.**Under the general direction of the Nurse Manager the Assistant Nurse Manager (ANM) practices within the Lahey Clinic Professional Practice Model, MA State nurse Practice Act and... 

Gracious Health Inc

Accountant/CPA Job at Gracious Health Inc

 ...We are looking for an Accountant/Strong Bookkeeper to manage all financial transactions, from fixed payments and variable expenses to bank...  ..., Finance or a relevant degree. Additional certification (CPA or CMA) is a plus. Education: ~ Bachelor's degree preferred...