Compliance Officer

3 days ago

Sydney, New South Wales, Australia beBeeQuality Full time $90,000 - $120,000
Quality Assurance Specialist

We are seeking a detail-oriented Quality Assurance Specialist to join our team.

The successful candidate will be responsible for conducting and reporting quality assurance audits as scheduled. This role will support the QA department in assessing compliance of clinical studies with applicable regulations, guidelines, study protocols, study workplans, and internal SOPs and policies.

Main Responsibilities:
  • Perform audits of facilities and studies for compliance with Good Clinical Practices (GCP), Good Clinical Laboratory Practices (GCLP), Standard Operating Procedures (SOPs), clinical protocols, applicable regulatory documents, and guidelines.
  • Review SOPs, Deviations/Event Investigations, CAPAs, 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, as applicable.
  • Perform 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 SOP contents are clear and consistent.
  • Assist QA Management in hosting sponsor audits and regulatory inspections.
  • Assist QA department in training personnel on SOPs and GxPs, as applicable.
Requirements:
  • University degree in a scientific area or equivalent.
  • 1-2 years QC/QA experience, preferably in a pharmaceutical/regulated environment.
  • Experienced in 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.
  • Experience with various experimental techniques an asset, including immunoassays, mass spectrometry.
  • Knowledge of US FDA, EMA, and Health Canada requirements on the conduct of clinical studies as they pertain to the activities of CellCarta.
  • Detail-oriented with excellent investigation and troubleshooting skills.
  • Strong commitment, self-motivated.
  • Excellent organization skills.
  • Proven flexibility to adjust to shifts in priorities, multitask while maintaining quality.
  • Ability to work well in a team environment.
  • Ability to identify and/or resolve quality issues in a proactive, diplomatic, flexible, and constructive manner.
  • Ability to design and implement quality processes and continuous improvement initiatives.
Bonus Points:
  • Additional certifications such as ISO 13485 or IQ/OQ/PQ preferred.

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