Job Title: CAPA Investigator Owner
Location: Round Lake IL
Duration: 12 Months
Description:
CAPA/NCR writers
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 client 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 product's 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.
Thanks & Regards,
Anupam Das
Manager- Recruitment & Sales
Direct Number: 346-658-2825 / 360-614-3032
115 Gemini St. Suite# 173 Houston, TX 77058
anupam@gandivainsights.com
...PROLIM ( is currently seeking Civil Structural Engineer for one of our top client in Newport News, VA Description: ***ABET Engineering degree required*** Analyzes, researches and develops structural engineering specifications involving metals, non-metallic...
...Our studio is growing, and we are seeking an Architectural Designer with a minimum of 8 years experience to join our team! Throughout all phases of the design process, our office requires people to work both collaboratively and independently. Our ideal candidate will...
...ClearChoiceMD is seeking a dependable full-time Medical Assistant or EMT for oururgent care centerin Scarborough, ME. Our ideal... ...weekend shift. Part-time hours are 8AM-8PM, 1-2 days per week. Travel: No travel is expected for this position however, depending on...
...organized and highly motivated individual for employment as an Entry Level Biologist to be based in Orange or Los Angeles, California office. This position would support numerous permitting, biological resource, and environmental planning and compliance projects. This...
In order to give our children better English education, we would like to hire an experienced full time English teacher who loves preschool teaching . We look forward you to join us.