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Quality Assurance Associate I

Axis Clinicals Llc
Dilworth, MN Full Time
POSTED ON 12/4/2024 CLOSED ON 2/3/2025

What are the responsibilities and job description for the Quality Assurance Associate I position at Axis Clinicals Llc?

Summary

The Quality Assurance (QA) Associate I will perform audits of the AXIS Clinicals system in order to ensure compliance with company SOPs, study protocols, and regulatory guidelines (GCP, GLP, etc.). While the QA Unit is independent of Operations, they will work closely with other departments (Clinical, Bioanalytical, etc.) to ensure active participation in continuous quality improvement activities.

Essential Functions

Plan and conduct randomized and routine internal audits (study, facility, processes, etc.) to ensure compliance with company Standard Operating

Procedures, study protocol, and regulatory guidelines.

Record and report audit findings to appropriate department personnel. Major and critical audit findings will be reported to the affected department's Senior

Management.

Assist with maintaining audit and CAPA (corrective and preventative action) tracking systems.
Review and revise QA processes and Standard Operating Procedures.
Independently interpret audit findings and understand regulatory guidelines in order to evaluate compliance.
Execute other duties as assigned.

Knowledge, Skills and Abilities

Communication
Technology Skills
Managing Priorities/Deadlines
Professionalism
Planning and organizing skills

Education Requirements

Required: High School Diploma or Equivalent.

Certification/Licensure Requirements (If Applicable)

Required: N/A

Experience Requirements

Preferred: 2 years experience in Quality Assurance, Clinical or Bioanalytical Research. 2 years working in a regulated industry. Previous work in a Contract

Research Organization (CRO) setting.
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