Quality Specialist | Park Avenue Cleanroom & Industrial Laundry Services
Park Avenue is a Gippsland-based cleanroom and industrial laundry serving pharmaceutical, healthcare, food and industrial clients. Our customers depend on product that meets strict hygiene and contamination-control standards, every batch, every time. Quality and confidence are our point of difference.
About us
Park Avenue is a Gippsland-based cleanroom and industrial laundry serving pharmaceutical, healthcare, food and industrial clients. Our customers depend on product that meets strict hygiene and contamination-control standards, every batch, every time. Quality and confidence are our point of difference.
The Role
You’ll join a newly structured Quality function, reporting to the Head of Quality. You’ll work on the floor alongside production supervisors and operators, owning site quality training and the validation programme, and supporting batch release and continuous improvement. This is a hands-on role, supporting the operations teams.
Validation, Batch Release & Continuous Improvement
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Plan and execute validation activities (processes, equipment, cleanroom garments) and maintain the documentation
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Review and release batches against customer and regulatory specifications
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Drive continuous improvement using root cause analysis, data and Lean tools to reduce defects, rework and rewash
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Raise, investigate and close non-conformances, CAPAs and customer complaints
Quality Systems and Supplier management
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Support and help maintain the QMS, including documents, non-conformances, CAPAs and complaints
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Support the supplier management process, including approved supplier records and evaluations
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Plan and conduct internal audits, and track findings through to closure
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Prepare for and support customer and certification audits, including hosting auditors, retrieving records and coordinating responses to findings
Training
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Own quality training for production operators: induction, GMP, GDP, gowning, contamination control & hygiene, SOPs and refreshers
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Build and update training content, deliver it on the floor, and verify operator competency
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Maintain the training matrix and competency records to audit standard
Quality Control
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Inspect inward goods and carry out in-process quality checks
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Organise equipment calibrations and servicing, and keep the records audit-ready
What success looks like in 12 months
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No quality escapes to pharma or healthcare clients
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Cleanroom re-validation complete and documentation audit-ready
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100% of production operators trained and verified, with the matrix current
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Calibration and servicing schedule on time
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QMS records, including non-conformances, CAPAs and supplier records, current and closed on time
About you
Essential:
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3+ years in QA/QC within a regulated environment (GMP, pharma, food, medical device or healthcare)
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Experience executing validation protocols and releasing product against specification.
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Experience designing and delivering workplace training, with confidence in front of operators
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Experience supporting internal or external audits
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Self-directed and proactive: you see the gap and fix it without being asked
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Rigorous with documentation and data
Desirable:
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Cert IV in Training & Assessment
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Cleanroom or cleanroom Laundry experience
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Knowledge of ISO 14644, AS/NZS 4146, ISO 9001 or PIC/S GMP
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Internal auditor training (e.g. ISO 9001 or GMP)
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Continuous improvement experience (Lean, 5S, PDCA)
Why Park Avenue
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A role with real ownership and visible impact on how quality is run
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A clear development pathway, with growth into a senior Quality role for the right person
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A dedicated Head of Quality to learn from and work alongside
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A growing business with blue-chip regulated clients
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Leadership that backs improvement and moves quickly
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Gippsland lifestyle with no city commute
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