CAPA /NCR Investigation Owner - AK R2

Description:

CAPA/NCR writers

12 months contract ; May extend

Onsite

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 Baxter 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.

#IND2

Job Types: Contract, Temporary

Pay: $50.00 - $57.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• Do you have BS/BA (4 years of university level education) in science, engineering or related field.?
• How many years of experience do you have with handling non-conformance (NCR) investigations and implementing corrective and preventive actions (CAPAs)?
• How many years have you worked in an environment where compliance with FDA regulations or other industry standards was required?
• How many years of experience do you have using TrackWise or similar systems for managing NCRs and CAPAs?
• How many years have you worked in a cGMP-related industry or clinical setting?
• 1. Are you a US Citizen or GCH? If on Visa please mention the Visa Status
• 2. Are you ready for background check and drug screen in accordance with the local law and regulations?
• 3. Please confirm your email address and contact number?
• 4. Cube Hub payroll is "Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy?
• 5. What is your Expected Pay Range?
• 7. When will be a good time to call you? / Please let us know a convenient time for us to contact you regarding this opportunity.
• Candidate must not be allergic to Penicillins or Cephalosporins

Pls confirm

Work Location: In person

Salary : $50 - $57