Quality Investigator: Complaints & CAPA

Verista, Inc.; Fishers (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Life Insurance

Disability Insurance

Tuition Reimbursement

Paid Time Off

Job summary

Verista, Inc. is seeking a Complaint Investigator / Quality Specialist in the United States. The role involves reviewing and investigating complaints, performing visual and functional assessments, and documenting history in Veeva.

You will work with data stewards and use root cause summaries to inform investigations. Candidates should demonstrate independent decision-making, prior prioritization skills, and the ability to deliver high-quality deliverables on time.

Qualifications

• Demonstrated capability to deliver on the QualitySpecialist Responsibilities.
• Capacity to make independent sound decisions and independently manage priorities.
• Demonstrated ability to generate high-quality deliverables independently by required due dates.

Responsibilities

• Review and investigate complaint information provided.
• Perform visual/functional assessment as required.
• Utilize Veeva to record and document Complaint History.
• Research Deviation, Batch Record Review, Design History File/FMEA Review, Product Safety Assessment and Product Impact Evaluation background information pertaining to complaint.
• Contact data stewards in order to gain more insight into complaint and gather data as needed.
• Utilize Root Cause Investigation Summary and CAPA Overview as necessary to inform investigation.
• Author Templates for basic complaints and complex complaints.
• Utilize Templates to expedite the investigation write-up process for future complaint investigations.

Skills

MS Word

MS Excel

PowerPoint

Job description

Verista, Inc. is seeking a Complaint Investigator / Quality Specialist in the United States. The role involves reviewing and investigating complaints, performing visual and functional assessments, and documenting history in Veeva.

You will work with data stewards and use root cause summaries to inform investigations. Candidates should demonstrate independent decision-making, prior prioritization skills, and the ability to deliver high-quality deliverables on time.