Quality Control Assistant

**Location**: Sydney
**Work Type**: full-time in a 12-months in Fixed Term Contract***

**About us**:
At SpeeDx, we are passionate about improving patient outcomes and specialize in
molecular diagnostic solutions that go beyond simple detection to offer
comprehensive information for improved patient management. With our
headquarters in Sydney, our technology supports clinical diagnostic products for
infectious diseases with a range of products in the market and a pipeline of research
and In Vitro Diagnostic (IVD) assays since 2009.

Our well-equipped offices and laboratories are centrally located at the Australian
Technology Park in Eveleigh (Sydney) and are easily accessible by rail. SpeeDx
believes our employees are pivotal to our success and reputation, therefore we strive
to offer true work/life balance with opportunity for further training and structured
career development.

We like to recruit the best talent to join our growing company that was awarded 2021
Australian Company of the Year at the AusBiotech and Johnson & Johnson Innovation
Industry Excellence Awards. Make no mistake, we expect a lot from our people as
they do of us. So, if you can rise to the challenge, we will provide you with a dynamic
and rewarding career.

**About the Role**:

- **12-month fixed term** contract as a Quality Control Assistant.
- Entry level** **opportunity with research on technologies to develop upcoming
- IVD products.- Working in an ISO 13485 accredited manufacturing environment.
- working with state-of-the-art diagnostic equipment.- Extensive training provided to ensure smooth transition to the role and the
- company.- Opportunity to grow your career in Molecular Diagnostic company for the right- Monday-Friday office hours.

**Your primary responsibilities will include**:

- Assist in manufacturing IVD products compliant with ISO13485 and CFR 21 Part

820.
- Perform quality checks during the manufacturing process.
- Perform quality control testing and other laboratory activities.
- Format and record test result data into Quality Control reports.
- Perform real time stability studies testing.
- Participate in the design transfer process.
- Maintain activity records and file all paperwork.
- File discrepancy reports to the lab for corrective action.
- Prepare technical reports.
- Prepare reagents and reference materials for lab testing.
- Organize reference materials as to be readily available to lab staff. Notify
- management when inventories are low or insufficient.- Clean lab benches, shelves, hoods, floors, and walls as needed to maintain a
- clean environment.- Operate standard molecular laboratory equipment.
- Work according to the organization’s laboratory safety, health and
- environment standards.- Communicate adjustments to managers and other staffs when necessary.
- Perform general housekeeping duties.

**Qualifications/ Technical & Specialist Skills/ Experiences**:

- A tertiary degree in science, qualifications BSc or equivalent.
- Previous experience in Medical Device manufacturing is highly desirable.
- Previous experience with qPCR is highly desirable.
- Working knowledge of laboratory and QMS environment.

**Personal attributes/ Interpersonal skills:
- Solid time-management skills and ability to work under pressure.
- Excellent communication skills in both written and verbal.
- Great interpersonal skills and team player attitude
- Keen and diligent work ethic with good people skills to work within this
- enthusiastic team.- Solid time-management skills and ability to work under pressure.
- Excellent communication skills in both written and verbal.
- Great interpersonal skills and team player attitude.

and indicate if you have full rights to work in Australia.