Job Description

CAPA Investigator Owner

Location: ONSITE - Round Lake, Illinois (60073)

Type : W2 contract (NO C2C OR THIRD PARTY)

Length : 12 month contract (Contract extension expectation)

Pay Rate – Negotiable depending on DIRECT-related experience up to $55 an hour

Work Authorization : Must be currently in the United States with active employment authorization documents without a Visa that will or currently requires sponsorship. Visa sponsorship is NOT available, NOW or in the FUTURE , for this position.

Description:

Essential Duties and Responsibilities:

• Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
• Execute implementation of CAPAs associated with NCR investigations.
• 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.
• Provide guidance and coaching on performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.

Qualifications:

• Candidate must not be allergic to Penicillins or Cephalosporins
• Understanding of the product’s intended use and manufacturing process
• Ability to prioritize multiple tasks to ensure compliance with regulations and standard operating procedures.
• Strong problem solving and analytical skills.
• Consultation and facilitation skills.
• Understanding of statistics in support of fact based decision making.
• Customer sensitivity / acumen and ability to interact with all levels of management.
• Experienced user of TrackWise preferred.
• Working knowledge of FDA Regulations and International Regulatory requirements.
• Understanding of risk management tools.
• 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.

Important information: To be immediately considered, please send an updated version of your resume to [email protected].

***(Kelly Services does not expense relocation or interview costs)***

In addition to working with the world’s most recognized and trusted name in staffing, Kelly employees can expect:

• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs

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