Quality Assurance Specialist - GMP & Batch Release

Auspep; Melbourne; On-site; AUD 70,000 - 100,000; Full time

Job summary

Auspep, an Australian manufacturer of R&D and GMP chemicals, is seeking an experienced Quality Assurance Officer. You will ensure products released for distribution meet their intended purpose, and that the Quality system and processes comply with regulatory guidelines.

Reporting to the QA Manager, the role offers a supportive team in a flexible and inclusive workplace. Applicants with strong QA experience in pharma manufacturing will be valued.

Qualifications

• Tertiary qualifications in science, engineering or related field.
• Strong Quality experience in a manufacturing environment, preferably pharmaceuticals.
• 2+ years demonstrated experience in QA role. GMP experience is desirable.
• QC experience or knowledge of HPLC and other analytical testing would be advantageous.
• Validation experience would be desirable.

Responsibilities

• Reviewing batch manufacturing records and releasing raw materials, intermediates and final product.
• Preparing reports for deviations, OOSs and change controls.
• Preparing, reviewing and approving procedures, test methods and manufacturing records.
• Contributing to troubleshooting investigations and quality risk assessments.
• Participating in internal audit program.
• Providing training as required in Quality principles and GMP.

Skills

Quality assurance

GMP

Analytical testing

Technical writing

Education

Science/Engineering degree

Tools

HPLC

Microsoft Word

Microsoft Excel

Job description

Auspep, an Australian manufacturer of R&D and GMP chemicals, is seeking an experienced Quality Assurance Officer. You will ensure products released for distribution meet their intended purpose, and that the Quality system and processes comply with regulatory guidelines.

Reporting to the QA Manager, the role offers a supportive team in a flexible and inclusive workplace. Applicants with strong QA experience in pharma manufacturing will be valued.