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DivIHN Integration Inc

CAPA/NCR Writer

Round Lake, IL · On-site

... temporary and permanent talent. Visit us at -a-job/ to learn more and view our open positions ... Essential Duties and Responsibilities: 1. Perform non-conformance (NCR) investigations within the ...

Merican

Medical Writer

Temporary Assignment Duration: 5 Months Work Type: Remote Shift: Mon-Fri 9.00 AM-5.00 PM * We are ... Investigator's Brochures (IBs) * Informed Consent Forms (ICFs) * Common Technical Document (CTD ...

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CAPA/NCR Writer

CAPA/NCR Writer

DivIHN Integration Inc

Round Lake, IL • On-site

Contractor

Posted 13 days ago

Job description

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.

 
Please apply or call one of us to learn more

For further inquiries regarding the following opportunity, please contact our Talent Specialist:
Hema Malini at (630) 847 0275
 
Title: CAPA/NCR Writer
Duration: 06 Months
Location: Round Lake, IL
 
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

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 
14. Hands-on experience with TrackWise or a similar quality management system 
15. Experience conducting investigations related to CAPA and NCRs 
16. Strong technical and compliance writing skills
17. Experience with pharmaceutical investigations is a plus
Education and/or Experience:
• BS/BA (4 years of university level education) in science, engineering or related field is required.
•2-5 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.
 

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.