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 great role to work with others in Warehouse, Production, Project Managers at Melbourne.
Primary Responsibilities
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
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies.
We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.
We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience.
Our people make all of this happen, so providing an industry leading experience for our people is equally as significant.
By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers.
We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program.
We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
#J-*****-Ljbffr

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