CAPA / NCR Specialist

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at https : / / divihn.com / find-a-job / to learn more and view our open positions.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists.

Meghna at (224) 369-4230

Hema at (630) 847-0275

Title : CAPA / NCR Specialist

Location : Round Lake, IL

Duration : 12 Months (possibility of Full time conversion)

Onsite - 5 days / week but sometimes could be flexible

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 and International Regulatory and client 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.

3-5 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

Skills

Candidate must have experience with change control processes and interacting with auditors.

Strong skills in investigation writing and root cause analysis are required.

Managing 5 active investigation at a time.

Able to manage multiple cases efficiently while maintaining quality and compliance

Interview process : 2 rounds - 1st round virtual and 2nd round onsite

About us :

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.