Job Description

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Quality Assurance Associate

Advertiser: Agilex Biolabs Pty LtdMore jobs from this company

Job Information

Job Listing Date
22 Sept 2020
Location
Adelaide
Work Type
Full Time
Classification
Science & Technology, Quality Assurance & Control

Quality Assurance Associate

Agilex Biolabs is a Regulated Bioanalytical laboratory which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.  

We recognise that our people are our most valuable asset. It is through our employees’ integrity, expertise and hard work that we can provide high quality bioanalytical services. We are committed to providing a challenging and stimulating environment where what our people do matters.

Opportunity

Due to continued growth, an opportunity has arisen for motivated, talented and personable Quality Assurance Associate to join the team at Agilex. You will be responsible for supporting the quality audit program by performing internal audits as required by the audit plan ensuring the facility complies with regulatory requirements and under the direction of more senior QA staff members.

Responsibilities

  • Under guidance, conduct basic internal study audits of regulated bioanalytical projects in support of validation and clinical studies
  • Under guidance, conduct basic internal facility and process audits to verify operational compliance with internal processes and applicable regulatory requirements
  • Under guidance, review and approve study deviations which relate directly to their audited studies.
  • Evaluate audit findings, prepare and distribute reports to internal stakeholders, and review and accept corrective action responses with assistance from more senior QA team members.
  • Assist with audits and inspections conducted by sponsors as directed by more senior QA team members

What you'll need to succeed

Reporting to the QA Manager you will need:

  • Bachelor degree, preferably in a life sciences field
  • Exposure to, or theoretical knowledge of, quality principles
  • An aptitude for quality, an eye for detail, and the ability to read and follow written instructions
  • Ability to organize and manage multiple priorities
  • Proven ability to deliver tasks on time and with a high degree of accuracy
  • Good written and verbal communication skills
  • Intermediate MS Office Suite with the ability to prepare reports and verify calculations in word and excel
  • Ability to adhere to all safety regulations and procedures
  • Ability to interact with the QA and scientific staff at all levels.
  • Previous experience in a Quality Assurance role with formal audit training or equivalent experience will be highly regarded.

To Apply

  • To apply for this role please click on the 'apply for this job' link and submit your CV along with a cover letter outlining your skills and experience, please submit as one MS Word or PDF document.
  • We thank all applicants for their interest, however we will only contact you directly, should you be successful to be shortlisted through to the next stage of our recruitment process.
  • To be considered for this role you must be an Australian citizen, permanent resident or have an appropriate working visa.

www.agilexbiolabs.com

 

Agilex Biolabs is a Regulated Bioanalytical laboratory which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.  

We recognise that our people are our most valuable asset. It is through our employees’ integrity, expertise and hard work that we can provide high quality bioanalytical services. We are committed to providing a challenging and stimulating environment where what our people do matters.

Opportunity

Due to continued growth, an opportunity has arisen for motivated, talented and personable Quality Assurance Associate to join the team at Agilex. You will be responsible for supporting the quality audit program by performing internal audits as required by the audit plan ensuring the facility complies with regulatory requirements and under the direction of more senior QA staff members.

Responsibilities

  • Under guidance, conduct basic internal study audits of regulated bioanalytical projects in support of validation and clinical studies
  • Under guidance, conduct basic internal facility and process audits to verify operational compliance with internal processes and applicable regulatory requirements
  • Under guidance, review and approve study deviations which relate directly to their audited studies.
  • Evaluate audit findings, prepare and distribute reports to internal stakeholders, and review and accept corrective action responses with assistance from more senior QA team members.
  • Assist with audits and inspections conducted by sponsors as directed by more senior QA team members

What you'll need to succeed

Reporting to the QA Manager you will need:

  • Bachelor degree, preferably in a life sciences field
  • Exposure to, or theoretical knowledge of, quality principles
  • An aptitude for quality, an eye for detail, and the ability to read and follow written instructions
  • Ability to organize and manage multiple priorities
  • Proven ability to deliver tasks on time and with a high degree of accuracy
  • Good written and verbal communication skills
  • Intermediate MS Office Suite with the ability to prepare reports and verify calculations in word and excel
  • Ability to adhere to all safety regulations and procedures
  • Ability to interact with the QA and scientific staff at all levels.
  • Previous experience in a Quality Assurance role with formal audit training or equivalent experience will be highly regarded.

To Apply

  • To apply for this role please click on the 'apply for this job' link and submit your CV along with a cover letter outlining your skills and experience, please submit as one MS Word or PDF document.
  • We thank all applicants for their interest, however we will only contact you directly, should you be successful to be shortlisted through to the next stage of our recruitment process.
  • To be considered for this role you must be an Australian citizen, permanent resident or have an appropriate working visa.

www.agilexbiolabs.com

 

The application form will include these questions:
  • Which of the following statements best describes your right to work in Australia?
  • How many years' experience do you have in a quality assurance (QA) role?
  • What's your expected annual base salary?
  • How much notice are you required to give your current employer?

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