Senior Quality Auditor

13 hours ago

Australia beBeeQuality Full time $60,000 - $90,000

Job Summary

Quality Assurance Associate Position Overview

The Quality Assurance Associate will be responsible for conducting quality assurance audits, assessing compliance with regulatory requirements, and supporting the QA department in ensuring the highest industry standards are met.

Key Responsibilities:
  • Conduct quality assurance audits and reporting
  • Assess compliance with Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), clinical protocols, applicable regulatory documents, and guidelines
  • Review SOPs, deviations, event investigations, CAPAs, and change control documents to ensure compliance
  • Audit study workplans, perform in-life process audits, study data audits, and study reports
  • Conduct facility audits, including equipment maintenance, training records, computer software validations, and supplier qualifications as applicable
  • Keep management informed of all findings and follow up on corrective action implementation
  • Assist in writing or revising QA SOPs, as applicable
  • Review QMS SOPs to ensure clarity and consistency
  • Assist QA Management in hosting sponsor audits and regulatory inspections
  • Generate metrics for quality management reviews
  • Train personnel on SOPs and GxPs as applicable
  • Coordinate and interact with other departments to ensure corporate, departmental, and study goals are met
Requirements

University degree in a scientific area or equivalent

1-2 years QC/QA experience, preferably in a pharmaceutical/regulated environment

Experience writing and reviewing SOPs

Clear and concise written and verbal communication in English

Knowledgeable on drug development, validation of analytical methods, quality assurance, and regulatory compliance

Experimental techniques an asset, including immunoassays, mass spectrometry, etc.

Knowledge of US FDA, EMA, and Health Canada requirements

Detail-oriented, excellent investigation, and troubleshooting skills

Strong commitment, self-motivated

Excellent organizational skills

Proven flexibility to adjust to shifts in priorities, multitask while maintaining levels of quality

Ability to work well in a team environment

Benefits

Competitive compensation package

Employee annual incentive plan

Professional, dynamic, and stimulating work environment

About Us

Join our organization as we make a positive impact on human health and well-being.

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