We are seeking a dedicated and experienced professional to support the development, implementation, and maintenance of Quality Control functions across our operations.
This role is critical in ensuring our products consistently meet required standards and specifications through oversight of key QC activities, including lot release testing, stability studies, environmental monitoring, and incoming material inspections in line with our quality system.
Key Responsibilities:
* Support the Quality Control function and QC Testers to ensure daily tasks and business needs are met with regard to regulatory compliance and product quality.
* Testing of incoming goods, intermediates, and finished goods.
* Maintenance and calibration of QC testing equipment.
* Support the development and implementation of methods and procedures for inspecting, testing, and evaluating the identity, purity, and safety of raw materials, intermediates, and finished products, ensuring their conformity to approved specifications and regulatory requirements
* Prepare, validate and update Test Methods; maintain their currency with approved standards
* Participate in the preparation and/or review of protocols and reports for stability testing, new methods development, and third-party analyses
* Manage documents and records in accordance with practices.
* Identify opportunities for improvement in QC processes and implement changes as needed
* Monitor data trends and recommend corrective actions, as required.
* Provide input and advice to support Regulatory, Quality and Manufacturing.
* Assist with reports related to customer complaints and Out-of-Specification results.
* Mentor and develop QC staff
* Act as 2IC to QC Manager
Requirements:
* Bachelor's degree in Chemistry, Biology, or a related field
* Minimum of 4 years of experience in a quality control role within the pharmaceutical or medical device industry.
* Knowledge of analytical equipment software is an advantage (e.g., FTIR, HPLC, GPC)
* Experience working in a highly regulated environment (GMP, etc.) is an advantage.
* Some experience with polymers preferred.
* High level of experience working autonomously and within a team environment.
* Strong analytical skills, attention to detail. Ability to analyse data to identify sources of variability or error.
* Proficiency in testing methods and equipment.
* Excellent communication and teamwork skills.
* Proficient in Microsoft Office.
* Ability to take accountability for the quality and timeliness of their work outputs.
About Our Company:
We are a multinational company dedicated to redefining healing for the benefit of our patients.
We offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry.
What We Offer:
* A diverse, inclusive and flexible workplace culture
* Career development opportunities and unlimited access to online learning
* Rewards platform with access to discounts at over retailers
* Paid parental leave for primary and secondary carers, Nurture Days, and more
* Salary packaging including novated car leasing.
How to Apply:
Please send your resume by clicking on the button.
Please note that only shortlisted candidates will be contacted.
Please note only applicants with full working rights in Australia will be considered.