QC Associate (Inspection)

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 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

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.