Senior Quality Control Associate

About the role

Join Moregate Biotech as a Senior Quality Control Associate and lead daily laboratory operations to ensure products, processes, and documentation meet the highest quality and compliance standards. This permanent, full‑time position is based onsite at our Bulimba facility.

Key responsibilities

• Lead QC lab activities including testing, scheduling, and resource planning.
• Maintain compliance with GLP, GMP, ISO 9001, and safety standards.
• Review, approve, and sign‑off analytical results and related documentation.
• Manage external testing providers and coordinate gamma irradiation services.
• Investigate deviations, OOS/OOT results and drive CAPA implementation.
• Oversee method development, validation, and stability programs.
• Ensure audit readiness and support internal and external audits.
• Coach and develop QC team members while fostering a positive culture.
• Collaborate with QA, Production, and cross‑functional teams.

Required profile

• Tertiary qualification in Chemistry, Microbiology, Biochemistry, Biotechnology or related field.
• 3‑5 years of QC experience in regulated manufacturing environments.
• Hands‑on experience with GLP/GMP/ISO 9001 quality systems.
• Demonstrated leadership, organisational, and problem‑solving abilities.
• Commitment to safety, quality, and continuous improvement.

Required skills

• Endotoxin testing
• ELISA techniques
• Microbiology testing
• Basic chemical testing
• Method development and validation
• Stability study execution
• CAPA management
• Audit support
• GLP, GMP, ISO 9001 compliance knowledge

What we offer

• Key leadership role in a growing global biotech company.
• Supportive, collaborative team environment.
• Opportunities for professional growth and development.