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