QA Assistant

Are you passionate about maintaining the highest standards in biotechnology? Do you have a commitment to detail? Join a growing immunohaematology company as Quality Assurance Assistant.

**MAIN DUTIES OR RESPONSIBLITIES**
- Review and approve manufacturing and QC batch records in a timely manner.
- Issuing batch release documentation, liaising with Notified Bodies and external test labs to coordinate release of product.
- Release of product in SAP and communicating product release status to relevant departments.
- Evaluation and re-evaluation of suppliers, ensuring compliance and certification are met.
- Managing the training register, training records, and identifying training needs.
- Participate in internal and external audits.
- Maintenance of Quality Registers (e.g., Document control, Document distribution, customer complaints, UDIs, suppliers, etc.)
- Assisting with product registrations in Europe, Australian and in countries where product is distributed.
- Assist with preparing, reviewing, and maintaining Quality Documents (e.g. SOP’s, Work Instructions, etc).
- Releasing of quality documents for each Department.
- Assist with managing change control, Non-Conformances, and CAPAs.
- Assist with the complaint handling process.
- Liaise closely with key departments to ensure smooth execution of quality processes and provide advice relating to Quality Assurance.
- Maintain quality related trending.
- Assist with management review activities.
- Assist with other Quality Assurance activities as requested.

**QUALIFICATIONS**
- Diploma or degree level qualifications in Science is preferable

**SKILLS**
- Strong Quality Assurance skills
- Strong attention to detail and analytical skills
- Capable of readily adapting and displaying flexibility
- Ability to work independently and collaboratively in a team
- Intermediate Microsoft Office skills (Word, Excel, PowerPoint, and Outlook)
- Good verbal and written communication
- Organized and able to meet deadlines
- Highly motivated
- Ability to prioritize work load
- Good problem-solving skills

**PERFORMANCE GOALS**
- Achieving quality targets
- Detection of product non-conformities
- Process effectiveness
- Implementing continuous improvement
- Efficiency in resolving quality issues
- Efficiency in device registration submissions
- Maintaining documentation and compliance records
- Promoting awareness of the QMS throughout the company
- Deal with clients, suppliers, and other employees professionally at all times

**Job Types**: Full-time, Permanent

**Salary**: $70,000.00 - $75,000.00 per hour

Expected hours: 37.5 per week

Schedule:

- 8 hour shift
- No weekends

Application Question(s):

- Are you an Australian resident?

Work Authorisation:

- Australia (required)

Work Location: In person