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.
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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