## QC Associate (Inspection)Apply: Moorabbin, AUS: Full time: Posted Today: JR******Life changing therapies.
Global impact.
Bridge to thousands of biopharma companies and their patients.
**We are PCI.
**Our investment is in People who make an impact, drive progress and create a better tomorrow.
Our strategy includes building teams across our global network to pioneer and shape the future of PCI.An exciting opportunity has arisen in the Quality Operations team.
It's a supporting role in the creation, review and approval of Incoming and Dispatch documentation required for internal PCI release and dispatch.
This will enable timely and accurate review/disposition of material/product records and physical product checks in various temperature conditions compliant with GMP and Client/Sponsor requirements.
It also supports 'Quality On the Floor' activities for oversight and prompt issue resolution.
It's a outstanding role to work with others in Warehouse, Production, Project Managers at Melbourne.
***Primary responsibilities of this position are:*** * Receipt, testing and disposition of incoming materials/products for use in Production or Distribution* Creation and review of materials/product specifications* Issue and archive documentation pertaining to incoming/dispatch material/product records, test records and specifications* Support the assessment of returned materials/products and the required documentation for disposition* Update inventory management system for dispositioned materials/products and products intended for destruction* Perform Pre-Dispatch inspection in warehouse according to PCI procedures to ensure products have been correctly picked, prepared and shipped according to Client/Sponsor orders.




* Conduct product inspection in different storage condition warehouses e.g. Ambient, 2-8°C and -20°C conditions.
* Support the ongoing management of retention samples* Review Warehouse documentation and logs to ensure compliance with Good Documentation Practices* Complete, review and support site investigations/escalations for the determination of root cause/impact/risk for EVENTs, Deviations, Complaints, Non-Conformance and change controls.
* Support the completion of internal, client and regulatory inspections, including the response to findings and completion of corrective and preventative actions* Support applications and management of import / export permits* Create and review operational SOPs/WI/Forms (as required)* Support mock recall and recall activities instigated by PCI or clients* Action continuous improvements to enhance Quality Operations performance, compliance to regulatory requirements and improvements in site Standard Operating Procedures (SOPs)* Report metrics related to Incoming Release and assist with the preparation of Quality Management Review information* Support the completion of other Quality Operations team responsibilities as required (e.g., Product/Material Inspections, product specification file creation etc)* Ensure all activities in area of responsibility are performed in accordance with GMP, company SOPs and Health and Safety policies.




* Escalate quality issues to the Quality Control Associate Manager and Quality Operations Manager* Other activities as directed by the Quality Control Associate Manager and Quality Operations Manager ***Qualifications & Experience required:**** Bachelor of Science or related discipline* Experience in a Quality role in cGMP pharmaceutical environment* Proficient user of Microsoft Word and Excel* Use of quality management system and inventory management system software in a regulated industry ***Competencies required:**** Positive, embraces and responsive to change* Clear communication and collegiate* Positive, 'can-do' attitude, embraces and 'lives' PCI's Vision, Values and Pristine Customer Service* Analytical thinker and solution finder/problem solver* Collaborative, team player* Objective and robust decision maker* Excellent interpersonal, written and verbal English communication skills* Self-motivated and achievement orientated* Trusting and trustworthy* Conscientious and diligent* Compliance and adherence to PCI procedures and policies* Competent in written and verbal skills, with good attention to detail* Ability to work in fast-paced environment* Positive, embraces and responsive to change* Flexible with managing workload in line with business priorities* Effective time management **This position:*** Is onsite role, at the PCI Melbourne site in Moorabbin.
* Requires a motivated, can do, level-headed individual with the ability to encourage a positive attitude in team members* Fosters a culture of work life balance, wellbeing and resilience* Is office and Warehouse based; desk/computer work required in Ambient, 2-8°C and -20°C conditions
#J-*****-Ljbffr

📌 Qc Associate (Inspection) (Melbourne)
🏢 PCI TRGR Penn Pharmaceutical Services
📍 Melbourne