Who are we?
We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field.

Why should you join Avance Clinical?
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.
We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

The role
Working remotely the Senior Quality Assurance (QA) Associate is responsible for supporting the development, implementation and maintenance of the quality assurance program and related policies and procedures to ensure compliance with Good Clinical Practices (GCP) and other regulations for our U.S based operations.

Responsibilities

• Internal study audits (Trial Master Files, Study Databases and Clinical Study Reports) to ensure compliance with applicable regulatory and organisational procedures
• Internal process audits to verify compliance with internal processes and applicable regulatory requirements
• Assist with vendor audits and audits conducted by sponsors
• As required, contribute as a member of the investigational team for CAPAs
• Coordinate preparation, review and issue of Standard Operating Procedures (SOPs) to support and maintain Avance Clinicals’ quality systems
• Maintain an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in the U.S

Qualifications, Skills and Experience

• Bachelor’s degree in a life science field
• Minimum 2 years’ experience as a Quality Assurance professional operating in a GCP environment in the U.S
• FDA inspection experience is highly desirable including good knowledge of CFR
• Formal audit training or evidence based internal / study audit training
• ICH-GCP training
• Ability to prioritise work, manage multiple priorities and deliver tasks on time with a high degree of accuracy
• Good written and verbal communication skills with a demonstrated ability to communicate effectively with senior management and other departments
• A proactive and enthusiastic team player who is willing to work in, and be supportive of, a positive and dynamic team culture
• Intermediate MS Office suite.

What we offer

• Stimulating work
• Project diversity
• An intellectual challenge
• An agile & flexible workplace
• Opportunity to progress
• Stability
• Sense of community
• A leadership team that are working together on a common goal
• Flexible work options
• Great tools / tech to do your job
• A competitive salary & an extra days holiday for your birthday!

What next?
As a growing business we’re looking for likeminded people to join us – we hope that’s you.

• To join our team please submit your CV & cover letter as one Microsoft Word document
• You must have full U.S working rights to be considered

Adrian Bedford, Talent Acquisition Specialist, Avance Clinical, Australia, 0406 574234 / Adrian.bedford@avancecro.com


At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.