Senior Quality Control Analyst

2 weeks ago


Port Melbourne Victoria, Australia PolyNovo Limited Full time $100,000 - $140,000 per year

Who We Are

PolyNovo is a disruptive medical technology company, headquartered in Melbourne. We design, develop, and manufacture innovative dermal regeneration solutions, using our patented bioabsorbable polymer technology NovoSorb. Our lifesaving products have revolutionised the treatment of burns, major trauma as well as multiple emerging indications, and impacted the lives of over 70,000 patients globally.

With a footprint in 46 countries and 300+ staff across a range of locations, PolyNovo continues to grow, and opportunities await. Learn more about PolyNovo by visiting our Website or our LinkedIn page.

About The Role

We are seeking a dedicated and experienced professional to support the development, implementation, and maintenance of Quality Control (QC) 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.

In this position, you will take a lead role in driving QC initiatives, maintaining robust QC systems, and providing expert technical support to cross-functional teams. Your contributions will directly support product quality, compliance, and continuous improvement.

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 GMP 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 GMP practices.
  • Identify opportunities for improvement in QC processes and implement changes as needed
  • Monitor data trends and recommend corrective actions, as required.
  • Provide technical input and advice to support Regulatory, Quality and Manufacturing.
  • Assist with investigatory reports related to customer complaints and Out-of-Specification results.
  • Mentor and develop QC staff
  • Act as 2IC to the QC Manager

About You

  • Bachelor's degree in Chemistry, Biology, or a related field
  • Minimum 7+ years of experience in a quality control role within the pharmaceutical or medical device industry.
  • Demonstrated ability to supervise and train junior staff.
  • Experience in method and equipment validation to meet regulatory and quality standards.
  • 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 QC testing methods and equipment.
  • Excellent communication and teamwork skills.
  • Proficient in Microsoft Office.
  • Proven ability to take accountability for the quality and timeliness of their work outputs.

Why PolyNovo?

Join a team that values innovation, collaboration, and professional growth. At PolyNovo, 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.

  • Multinational, ASX 200-listed and values-led business dedicated to redefining healing for the benefit of our patients
  • Unique platform technology, an exciting pipeline of highly innovative products
  • Diverse, inclusive and flexible workplace culture
  • Career development opportunities and unlimited access to online learning
  • Rewards platform with access to discounts at over 450+ Australian retailers
  • Paid parental leave for primary and secondary carers, Nurture Days, and more
  • Salary packaging, including novated car leasing.

Apply Today

Please send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted.

Please note that only applicants with full working rights in Australia will be considered.

PolyNovo is committed to creating a workplace that values equity, diversity, and inclusion. We recognise and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed.



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