Senior QA Associate

About the company/role:

• This company specializes in pharmaceutical manufacturing and is based in the Eastern suburbs.
• The company provides flexible and comprehensive services, from early-stage API development to scaled commercial manufacturing for global distribution.
• The company’s core values are accountability, leadership, curiosity, quality, innovation, and driving results.
• They are seeking an experienced Senior QA Associate to join their team on a contract basis with potential to extend.

As this is a short-term contract, WHVs with a strong QA background in pharmaceuticals are encouraged to apply!

Duties:

The Senior QA Associate is responsible for providing senior level advice and execution of the quality framework for the company. The ideal candidate will have QA documentation experience along with a microbiology background to assist in sterility assurance activities. Your duties may include but are not limited to:

• Assist with QA documentation review for project documents (qualification/validation), QC test methods, vendor approval documentation/risk assessments)
• Provides in process audit and review of trends and data and in partnership with clients and Quality Management to support the internal review and audit of practices and processes
• Plays an active role in ensuring the company is in an audit ready state and supports the preparation and participation in regulatory audits with regulatory bodies and key clients and stakeholders.
• Is a key input and support for clients in helping drive Quality Management Review activities to identify and implement improvements and actions and partnering with the organization to achieve key outcomes
• Provides in process audit and review of trends and data and in partnership with clients and Quality Management to support the internal review and audit of practices, process to ensure IDT delivers on its Quality goals and regulatory commitments

About you:

• Bachelor of Science majoring in Microbiology or related discipline
• 4-5+ years experience in the pharmaceutical or biotechnology industry with a demonstrated operations, process development/validation and quality background
• Experience in sterility assurance and environmental monitoring
• Demonstrated capability applying key cGMP, Quality, Validation, Scientific and Testing processes and systems to ensure effective process and manufacture
• Strong interpersonal skills to consult, advise and partner with client groups

 
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).  
Or, if you have any questions, please contact Sarah or Cathy on 03 9040 1630.

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.