Quality Assurance Associate

Operating in the eastern suburbs of Melbourne this ultra-modern contract-testing laboratory is seeking a full time Quality Assurance Associate with sound analytical skills for an immediate start.

Accredited with the TGA and APVMA the high-tech facilities encompass a broad range of analytical equipment primarily used in the Pharmaceutical Veterinary and Bioanalytical sectors.

The successful candidate will be self-motivated and capable of hitting the ground running in a fast-paced friendly environment ready to provide sound theoretical and practical knowledge to a dedicated team of like-minded professionals.

Candidates must possess sound knowledge & experience in cGMP quality systems document control computer systems administration quality risk management change control laboratory investigations and CAPAs. Additional experience in auditing will also be highly regarded.

Job responsibilities include:

• Performing the QA role in supporting laboratory investigations including root cause analysis quality risk management collaboration with stakeholders / SMEs to resolve and develop effective CAPAs
• Creation update and review of quality procedures and documentation including protocols validations test methods and reports
• Coordinate and collaborate with departmental heads / process owners / SMEs for timely completion of investigations CAPA change management and quality system activities
• Manage quality risk management quality registers quality system review and change controls including execution for timely completion
• Liaise with instrument / software vendors SME / process owners IT and validation department to ensure system configuration and administration is in line with cGMP and data integrity requirements
• Review computer systems / software lifecycle validations and performs computer systems audit
• Performs QA review for release of validation protocols/reports batch (analytical reports) test procedures and equipment/software/system qualification reports
• Internal and external audits/assessments
• Other pharmaceutical quality system requirements including equipment training and document management system.

Qualifications :

At a minimum a tertiary qualification in Science (preferably in Chemistry Biochemistry) as well as 3 years in a similar role within the pharmaceutical industry. Ideally you will also possess: 

• Extensive knowledge and experience in cGMP quality systems (PIC/S ICH 21 CFR 210/211 industry guidance BP/USP/Ph Eur standards)
• Sound knowledge and experience in managing laboratory investigations quality risk management CAPA and change control
• Excellent protocol and report writing skills with experience in quality (SOP test procedures) documentation  
• Experience in pharmaceutical quality system audit computer systems administration and equipment qualification/software validation will be an advantage 
• Excellent analytical skills attention to detail time management and organisational skills
• You are resourceful and meticulous
• Have demonstrated problem solving and decision-making skills
• Are self-driven and result oriented (able to manage and monitor quality tasks required and resolve challenges/issues to ensure requirements are met in a timely manner)
• Have excellent verbal and written communication skills
• Are a team player with collaborative attitude and ability to communicate effectively across multi-functional departments to achieve objectives and goals
• Have excellent Microsoft Word Excel and computer literacy skills
• And an ongoing passion to learn and continuously improve in a fast-paced environment.

Imperative to the successful operations of this highly respected testing facility is a strict understanding and adherence to the cGMP quality system consideration of time-sensitive workloads and the accurate and thorough recording of all results activities and deviations encountered during the varying stages of analysis.

Additional Information :

This is an excellent opportunity for a self-motivated person with a passion in Quality Assurance to join a dynamic company that can offer a rewarding career path.

If you feel that you can bring outstanding skills and a great attitude to our team please submit a cover letter curriculum vitae and be able to provide at least two recent professional references.  Applications will be treated with the strictest confidence.

This opportunity is only open to candidates who are eligible to work in Australia/New Zealand and already have work rights or an appropriate working visa.

Remote Work :

No

Employment Type :

Full-time