We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in ****, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.
Company
We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in ****, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.
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 *****, 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.
Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect,
teamwork, and innovation.
Specific Responsibilities
Performs chemical, physical, and instrumental testing of raw materials, in-process materials, and finished products in accordance with approved procedures and specifications.
Conducts routine and non-routine analysis, reviews analytical data, and ensures all results are accurately documented in accordance with GDP.
Prepares and reviews Certificates of Analysis and supports batch traceability and disposition activities using enterprise systems, including SAP QM.
Ensures laboratory equipment is calibrated, maintained, and fit for purpose, and support preventative maintenance activities.
Develops, verifies, validates, and maintains analytical methods and supports validation activities including IQ/OQ/PQ where required.
Maintains compliance with the QMS, GMP, and applicable regulatory requirements, and supports internal and external audit readiness.
Reviews and updates SOPs, work instructions, and QC documentation, and contributes to continuous improvement initiatives.
Participates in OOS, OOT, non-conformance, complaint, and laboratory investigations, including root cause analysis, reporting, CAPA support, and risk assessment.
Provides technical guidance and training to QC staff and acts as a subject matter expert for QC testing and methodologies.
Collaborates with QA, Production, and R&D; to support product quality, issue resolution, and effective laboratory operations.
Builds effective working relationships with peers and supervisors and support an efficient, productive QC team.
Key Relationships (internal and 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.
Essential Qualification/ Experience
Bachelor of Science in Chemistry or a related discipline.
Minimum 5 years' experience in a chemistry laboratory, preferably in a regulated manufacturing workplace.
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.
Essential Skills, Knowledge and Attributes
Personal Qualities
Quality-focused, compliance-driven, and accountable.
Solid 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.
Knowledge and Skills
Aware of SDI's current Quality policy and objectives
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.
#J-*****-Ljbffr
📌 Senior Quality Control Chemist (Melbourne)
🏢 SDI
📍 Melbourne