Job Description

Job Description

Job Title: QA Investigation Specialist (Full- time)

Job Location- Decatur, IL

Required Citizenship / Work Permit / Visa Status: USA Citizen/Green Card Holder/H1 Transfer/TN Visa (Canadians only)/OPT EAD

Job Description

Manages, implements and coordinates investigations program to assure that all excursions are adequately investigated for determination of root cause and that corrective and preventive actions are identified and implemented to prevent/reduce excursions in processes and procedures.

Essential Duties & Responsibilities:

• Responsible for the assignment, tracking, and monitoring of all investigations, corrective and preventative actions (CAPA), effectiveness checks (EC) and customer complaints at the Decatur site. Work with cross-functional personnel to ensure that a comprehensive investigation is performed, and effective corrective and preventive actions are created to prevent future occurrences of a deviation.
• Responsible for providing guidance to the investigators to ensure that all Decatur site investigations comply with regulatory requirements.
• Responsible for coordinating priorities for the Investigators to ensure timely closure investigations, CAPAs, ECs and customer complaints.
• Quality review and evaluation of all investigations, CAPAs, ECs and customer complaints.
• Assist during regulatory inspections, customer audits and internal audits as required.

Education and Experience:

• Bachelor’s degree required. Minimum of 4 -6 years' experience in a Quality role relating to investigations, corrective and preventative actions (CAPA), effectiveness checks (EC) and customer complaints.
• Must have experience in performing cGMP related training.

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