22 Oct
|
Eagle Labs Australia
|
Ormeau
22 Oct
Eagle Labs Australia
Ormeau
Eagle Labs is an Australian nutraceutical manufacturer specialising in the development and manufacture of gummies, tablets, capsules, powders and liquid dietary supplements. The company is committed to producing secure, high-quality products that comply with Australian food legislation and internationally recognised quality and food safety standards.
The QA Officer (In-Process QC) is a floor-based, hands-on, quality role. Majority of the role is spent on the production floor performing in-process quality control across the gummy and capsule lines: verifying line clearance and start-up, performing in-process inspection and testing, verifying CCP and prerequisite program controls, and controlling non-conforming product at the point it occurs.
The officer will also contribute to QA by monitoring and using initiative on SOPs, work instructions, forms and batch records, in-line with due process. The role brings practical manufacturing experience to the QA side and is the working link between what the documents say and what the line does.
Key Responsibilities — In-Process Quality Control
1. Line Clearance, Start-Up and First-Off Verification
- Verify line clearance performed by Production before batch start and at every product or batch changeover: removal of previous product, components, labels and documents; equipment and room cleaning status; status labelling.
- Verify pre-operational hygiene (visual inspection and ATP or swab testing where specified) before the line is released to start.
- Verify correct materials, batch-specific packaging components, label artwork version, batch code and best-before date against the batch record before first-off.
- Perform first-off checks against the approved specification and batch record and confirm start of run within delegated authority.
- Verify equipment start-up checks are complete, including balance verification, foreign-body detection challenge tests and coder set-up.
2. In-Process Inspection and Testing
- Perform in-process sampling,
inspection and testing at the frequency and against the limits set in the approved specification, sampling plan and batch record.
Gummies
- Verify cooking and depositing parameters recorded by Production against batch record limits.
- Perform or verify in-process tests such as piece weight, Brix, pH, water activity or moisture, appearance, texture and coating.
- Verify pouch packing: count or net weight, seal and zip integrity, presence of the dry card desiccant and code legibility.
Capsules
- Perform or verify fill weight and weight variation checks, capsule closure and appearance (splits, dents, incomplete locking).
- Verify bottling: count, induction seal integrity, cap application, presence of the silica gel desiccant, label and batch code.
All lines
- Draw in-process, finished product and retention samples, and samples for external laboratory testing, with documented chain of custody.
- Perform routine verification of QC instruments (balances, pH meter, water activity meter, refractometer) and escalate out-of-tolerance results.
3. HACCP / CCP and Prerequisite Program Verification
- Verify CCP monitoring records (including foreign-body inspection once the X-ray unit is commissioned) are completed at the required frequency, challenge tests are passed, and deviations are actioned as the HACCP plan requires.
- Conduct routine GMP and hygiene walkthroughs covering personnel hygiene and gowning, brittle materials, foreign-body controls, pest activity and housekeeping.
4. Non-Conforming Product and Point-of-Occurrence Response
- Place materials,
in-process product or finished product on QC hold when results fall outside limits or a control is compromised; apply hold status physically and in electronic record systems.
- Request a line stop where there is a product safety or quality risk, and escalate immediately to the Quality Manager and Production Supervisor.
5. Real-Time QC Records and Batch Documentation
- Complete QC records contemporaneously and in line with Good Documentation Practice (GDP).
- Review batch record sections on the floor as the batch progresses, so missing entries, calculation errors and out-of-limit values are found while they can still be corrected or investigated, rather than at final review.
KEY RESPONSIBILITIES — QA Systems and Gap Analysis
- SOP, Work Instruction and Batch Record Gap Analysis
- Deviation, CAPA and Change Control Support
- Training and Floor Coaching
ABOUT YOU
- Demonstrated in-process QC or production quality experience in food, nutraceutical, pharmaceutical or similar regulated manufacturing. A relevant qualification is desirable: Certificate IV or Diploma in Food Processing, Food Science and Technology, or Pharmaceutical Manufacturing, or a related degree.
- HACCP training, or willingness to complete it within the probation period.
- At least 3 years in QC or production quality roles in food, nutraceutical, pharmaceutical or similar regulated manufacturing, including hands-on in-process inspection and testing.
- Practical experience with line clearance, sampling, in-process testing and GDP.
- Demonstrated ability to work to SOPs and batch records and to identify where they do not work in practice.
- Clear written communication, sufficient to draft workable work instructions and forms.
- Comfortable working on a production floor, with flexibility to align with production start times.
- Proficiency with Microsoft Word and Excel; ability to work in an ERP system.
📌 Quality Assurance Officer (In Process QC) (Ormeau)
🏢 Eagle Labs Australia
📍 Ormeau