As a Junior QC Officer at Breathe Life Sciences, you will be responsible for quality control sampling of incoming materials - active pharmaceutical ingredients, excipients, labels and packaging materials - and for arranging, tracking and closing out testing of those samples at approved contract laboratories. You will sit at the control point between receipt of a material and its release for manufacturing use, ensuring no material is used before its identity and quality have been confirmed against the approved specification. Reporting to the Quality Assurance Manager, this entry-level role offers structured training and close supervision, with responsibility and autonomy increasing as competency is assessed and signed off.

RESPONSIBILITIES

- Sample incoming APIs, excipients, labels and packaging materials in line with site procedures and approved specifications, applying AQL sampling plans (ISO 2859-1 / ANSI Z1.4) for excipients and packaging materials.
- Sample herbal plant starting material and other APIs per pharmacopoeial requirements, including composite sampling, and take retention/reference samples for storage.
- Maintain sample labelling, chain of custody and traceability, taking care to avoid cross contamination and mix-up, and escalate any critical defects or out-of-specification observations to the QA Manager.
- Perform incoming inspection of material deliveries, complete receipt and inspection records, verify supplier Certificates of Analysis/Conformance and approved supplier status, and maintain quarantine and status labelling until release.
- Raise test requests against approved specifications,



prepare and dispatch samples to contract laboratories with correct chain of custody documentation, and ensure scheduled substances are dispatched securely.
- Maintain a live schedule of samples sent, tests pending and results outstanding, following up with contract laboratories to keep testing aligned with production needs.
- Receive, check and file test results and Certificates of Analysis, verify against specification, and maintain data integrity (ALCOA+); escalate out-of-specification or out-of-trend results for investigation.
- Handle scheduled materials and samples per vault access and controlled substance procedures, supporting stocktakes and reconciliation of controlled drug stock.
- Record all sampling, receipt and testing activity accurately and contemporaneously, raise deviations/non-conformances, support investigations and CAPAs, and assist with audits and inspections (TGA GMP, Office of Drug Control, Queensland Health).
- Complete assigned GMP and role-specific training, and work in accordance with site WHS requirements, reporting hazards, incidents and near misses promptly.

KEY REQUIREMENTS

- A qualification in science, chemistry, biotechnology, pharmacy or a related discipline, or equivalent practical experience gained in a GMP environment.
- Prior experience in pharmaceutical,



food or laboratory quality is desirable but not essential; a willingness and capacity to learn is essential.
- Understanding of, or demonstrated ability to quickly learn, GMP and the Australian regulatory framework (TGA, Office of Drug Control, Queensland Health).
- Ability to follow written procedures precisely and work accurately with numerical tables such as AQL sampling plans.
- Accurate, legible and contemporaneous record-keeping, with an understanding of data integrity principles (ALCOA+).
- Sound GMP sampling discipline, including representative sampling, chain of custody, sample integrity and avoidance of cross-contamination.
- Ability to gown and work in a clean manufacturing area in accordance with site procedures.
- Strong attention to detail, and the judgement to escalate rather than resolve matters outside the authority of the role.
- Ability to organise and prioritise a workload of concurrent samples and tests, keeping a testing schedule current under production pressure.
- Explicit written and verbal communication, and confidence dealing directly with contract laboratories, suppliers and internal stakeholders.
- Competent use of Microsoft Office and SharePoint and, ideally, an ERP or electronic quality management system.
- Physically able to safely lift, carry and manoeuvre material containers and bags weighing up to 25kg, using correct manual handling technique, and to work across warehouse and manufacturing environments.
- Eligible to work with scheduled substances and to satisfy any background or suitability checks required under applicable legislation.

📌 Junior QC Officer (Meadowbrook)
🏢 BREATHE LIFE SCIENCES
📍 Meadowbrook