Quality Assurance Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeQuality Full time
Quality Assurance Associate

We are seeking a Quality Assurance Associate to join our dynamic team. As a QA Associate, you will have the opportunity to use your expertise and skills to ensure that our services meet the highest industry standards.

The QA Associate is responsible for conducting and reporting quality assurance audits as scheduled. The QA Associate supports the QA department in assessing compliance of clinical studies with the applicable regulations, guidelines, study protocols, study workplans and internal SOPs and policies.

Responsibilities:
  • Performs audits of facility 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.
  • Reviews SOPs, Deviations/Event Investigations, CAPAs, change control documents to ensure compliance.
  • Audits study workplans, performs in-life process audits, study data audits and study reports.
  • Conducts facility audits including equipment maintenance, training records, computer software validations (CSV), as applicable.
  • Performs supplier qualifications as applicable.
  • Keeps management informed of all findings and follows up on corrective action implementation.
  • Assists in the writing or revision of QA SOPs, as applicable.
  • Reviews QMS SOPs to ensure SOP contents are clear and consistent.
  • Assists QA Management in hosting sponsor audits and regulatory inspections.
  • Assist QA Management in generating metrics for quality management reviews.
  • Assists QA department in the training of 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.
Key Requirements:
  • 1-2 years QC/QA experience, preferable 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, etc.
  • Knowledge of US FDA, EMA and Health Canada requirements on the conduct of clinical studies as they pertain to the activities of this role.
  • 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.
Working Conditions:
  • Actual job location is in Baulkham Hills, NSW 2153.
Benefits:
  • Competitive Compensation Package
  • Employee Annual Incentive Plan (EAIP)
  • Professional, Dynamic, and Stimulating Work Environment

About Us:

We are a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. We leverage our integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, to support the entire drug development cycle, from discovery to late-stage clinical trials. We operate globally with facilities located in multiple countries.

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