Senior QC Associate

IDT Australia is seeking an experienced Senior Quality Control Associate to join our Quality Control team and play a key role in the management and execution of pharmaceutical stability programs.

This is not a general analytical chemistry position. We are seeking a candidate with demonstrated experience in pharmaceutical stability studies, including the testing, analysis, interpretation and reporting of stability data for products in development and commercial manufacture.

Working closely with the QC Manager, you will provide technical expertise across stability programs, support protocol development, perform stability testing, trend results, contribute to product specifications, and assist in ensuring compliance with GMP and regulatory requirements.

Key Responsibilities

• Coordinate and perform testing of pharmaceutical stability studies for APIs and finished dosage forms.
• Support the preparation and execution of stability protocols and stability programs.
• Analyse, trend and interpret stability data to identify product quality and performance trends.
• Prepare technical reports and support product specification development.
• Participate in OOS, OOT, deviation and CAPA investigations.
• Provide technical guidance and mentoring to laboratory team members.
• Support continuous improvement, validation and qualification activities.
• Ensure all activities comply with GMP, data integrity and regulatory requirements.

About You

To be successful in this role, you will bring:

• A degree in Chemistry, Pharmaceutical Science, Analytical Science or a related discipline.
• Demonstrated experience working within a GMP-regulated pharmaceutical environment.
• Proven experience supporting or managing pharmaceutical stability programs.
• Strong understanding of stability testing requirements for products in development and commercial products.
• Experience generating, reviewing and interpreting stability data and trends.
• Strong working knowledge of HPLC, GC and other analytical techniques.
• Experience participating in OOS, OOT, deviation and CAPA investigations.
• Strong understanding of GMP, data integrity principles and pharmaceutical quality systems.
• Excellent organisational, communication and stakeholder management skills.

Highly Regarded

• Experience working within a CDMO environment.
• Knowledge of ICH stability guidelines.
• Experience supporting stability protocol development and product specification generation.
• Previous experience coaching or mentoring laboratory personnel.

Why Join IDT?

At IDT Australia, you will work with a team of highly skilled scientists and pharmaceutical professionals supporting the development and manufacture of medicines that improve lives. We offer a collaborative environment that values safety, quality, innovation, continuous improvement and professional development.

If you have a strong background in pharmaceutical stability programs and are looking to take the next step in your career, we would love to hear from you. Send your resume and cover letter to ***email_hidden***