Location Country
Australia
Vacancy Name
Senior QC Chemist
Employment Type
Full-Time
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 safe 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.
Strong 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.
Salary Minimum
$82,250.00
Salary Maximum
$82,250.00
