Senior Associate, Quality Assurance Compliance

2 weeks ago

Melbourne, Victoria, Australia Proclinical Staffing Full time
Senior Associate, Quality Assurance ComplianceSenior Associate, Quality Assurance Compliance

This range is provided by Proclinical Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

A$50.84/hr - A$56.84/hr

Direct message the job poster from Proclinical Staffing

Life Sciences Recruitment Consultant - GxP Quality Assurance & Technical at Proclinical Staffing

Proclinical is seeking a Senior Associate, Quality Assurance Compliance to join our client, a global Biopharmaceutical leader renowned for its innovation and commitment to delivering medicines to treat health conditions and improve quality of life. At their Broadmeadows site, they manufacture life saving blood plasma derived medicines.

Role Overview

Reporting to the Senior Manager Quality Assurance Compliance, the Senior Associate, Quality Assurance Compliance is responsible for the management of third party and regulatory inspections, internal audits and self-inspection programs in addition to intracompany and blood service quality agreements, supporting quality assurance activities, conducting gap assessments, preparing for inspections, and contributing to compliance initiatives.

Team Size: 10 people

Duration: 6-month contract

Start Date: ASAP

Hours: Standard Mon to Fri hours. May be overtime during inspections, willing to pay overtime or do time off in lieu.

Capacity: Mostly onsite, with 1 day from home

WHV: Yes - must be available for the full 6-month duration

Role Responsibilities

  • Gap assessments (Inspections require gap assessments)
  • Write Data reports data/reports and analyses to support quality reviews including: Annual Product Quality Reviews, plasma master file updates, site KPIs and the global and local quality metric reviews.
  • When there is an inspection on site – person will be involved in the inspection (eg collation of requests for front office to present to auditors)
  • The role is quite a varied role
  • Deviation clusters, blood bank and quality agreements
  • Preparation for inspections
  • Rectifying some gaps for example - for providing Alburex to China

Skills and Experience

  • 3+ years of experience in a quality compliance role within a regulated industry (ideally pharma)
  • Bachelor Degree in Science, Engineering or Pharmaceutical Science
  • Background in microbiology and/ or biochemistry (highly regarded)
  • Experience with electronic document management systems (eDMS) Information Databases and reporting such as Veeva and Trackwise systems
  • Demonstrated flexibility to manage changing priorities
  • Demonstrated ability for conceptual and analytical thinking with good judgement to reconcile ambiguities.

How to Apply

If this opportunity aligns with your experience and career goals, please click 'Apply Now' to submit your application.

For a confidential discussion or to learn more about this role, please contact Pamela Phoumavong via email at or call

About Proclinical

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

Seniority level
  • Seniority levelAssociate
Employment type
  • Employment typeContract
Job function
  • Job functionQuality Assurance and Science
  • IndustriesPharmaceutical Manufacturing and Medical Equipment Manufacturing

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