Location Country

Australia

Vacancy Name

Senior QC Chemist

Vacancy No

VN417

Employment Type

Full-Time

Duration

Division

Quality

Summary of Role

The Senior Quality Control Chemist is responsible for

- Ensuring laboratory testing activities are planned, performed, reviewed, and controlled to verify that raw materials, in-process materials, and finished products conform to established specifications and applicable regulatory requirements.

- Providing technical oversight within the Quality Control function, ensuring the effective implementation and maintenance of laboratory processes, and supporting continual improvement activities.

- Maintaining compliance with applicable Quality Management System requirements, including ISO 13485, FDA QMSR, and relevant medical device regulatory standards.

- Ensuring adherence to Good Manufacturing Practice (GMP), Good Documentation Practices (GDP)

- Conducting all activities in a safe and compliant manner, consistent with organisational health, safety, and environmental requirements.

- Contributing towards SDI Strategic Priorities.

- The position also supports GMP, Good Documentation Practices, and workplace health, safety, and environmental requirements, while demonstrating accountability, teamwork, respect, and innovation.

Specific Responsibilites

- Perform chemical, physical, and instrumental testing of raw materials, in-process materials, and finished products in accordance with approved procedures and specifications.

- Conduct routine and non-routine analysis, review analytical data, and ensure all results are accurately documented in accordance with GDP.

- Prepare and review Certificates of Analysis and support batch traceability and disposition activities using enterprise systems,



including SAP QM.

- Ensure laboratory equipment is calibrated, maintained, and fit for purpose, and support preventative maintenance activities.

- Develop, verify, validate, and maintain analytical methods and support validation activities including IQ/OQ/PQ where required.

- Maintain compliance with the QMS, GMP, and applicable regulatory requirements, and support internal and external audit readiness.

- Review and update SOPs, work instructions, and QC documentation, and contribute to continuous improvement initiatives.

- Participate in OOS, OOT, non-conformance, complaint, and laboratory investigations, including root cause analysis, reporting, CAPA support, and risk assessment.

- Provide technical guidance and training to QC staff and act as a subject matter expert for QC testing and methodologies.

- Collaborate with QA, Production, and R&D; to support product quality, issue resolution, and effective laboratory operations.

- Maintain secure laboratory practices, including the correct handling and disposal of chemicals and hazardous waste, in accordance with WHS and environmental requirements.

- Build effective working relationships with peers and supervisors and support an efficient, productive QC team.

Key Relationships (Internal & External)

- Quality Assurance Manager

- Manufacturing Manager and Production leads





- Quality Control personnel

- R&D; personnel

Job Environment

- Based in Bayswater, Melbourne, Victoria, with occasional travel to Montrose; the role may relocate to Montrose within 1–2 years.

- Working hours: 10-day fortnight.

Education Level

Bachelor's Degree

Essential Experience

- Bachelor of Science in Chemistry or a related discipline.

- Minimum 5 years’ experience in a chemistry laboratory, preferably in a regulated manufacturing environment.

- Robust knowledge of analytical chemistry, laboratory techniques, and QC systems.

- Understanding of GMP, data integrity, and medical device or pharmaceutical manufacturing requirements.

- Advanced computer literacy, including Microsoft Office; experience with technical data analysis software is advantageous.

Knowledge and skills

- Strong analytical skills, attention to detail, and documentation accuracy.

- Ability to interpret specifications, procedures, and technical data.

- Effective written and verbal communication skills.

- Ability to lead investigations and complete actions effectively.

- Good organisational and time management skills.

Personal Qualities

- Quality-focused, compliance-driven, and accountable.

- Strong analytical, problem-solving, and technical judgment skills.

- Collaborative, supportive, and able to work effectively both independently and within a team.

- Professional, reliable, adaptable, and committed to continuous improvement.

- Motivated to learn and maintain positive working relationships.

Classification Level

3

Currency

AUD

Salary Minimum

$82,250.00

Salary Maximum

$82,250.00

Salary Period

Per Annum

Benefits

📌 Senior QC Chemist (Australia)
🏢 SDI
📍 Australia