Quality Control Associate Incoming Receipts & Release

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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QC Associate-Incoming Receipt and Release
Department: Quality
Position reports directly to: QC Team Leader
The position’s line manager reports to: Quality Operations Manager
Position is Permanent / Full Time

Core Requirements & Expectations for all Roles
Environmental Health & Safety: Compliance with all Environmental, Health & Safety legislation and global and local policies, processes, procedures and expectations to ensure the safety, health and well-being of all people on-site at all times, including; employees, contractors, casuals, Interns, work
experience students etc. and the environment.
Quality: Compliance with all GMP & PIC/S legislation, practices and requirements and global and local Quality policies, processes, procedures and expectations to ensure the safety, efficacy and stability of our products and services.
Behaviors: Inspire, Engage and Communicate Respect, Trust, Empower and Cooperate transparent, Ethical and Accountable Continuous Improvement and Results Driven with a Sense of Urgency Respectfully Challenge and Give Feedback to Develop our Potential

Purpose & Description of the Role (brief overview)
Purpose: The purpose of the Quality Control (QC) Associate-Incoming Receipt and Release is to support the QC Team Leader in ensuring PCI procedures are adhered to for the receipt, testing and management of incoming materials at PCI. All aspects of this role are performed in accordance with the Therapeutic Goods Administration Release for Supply of Medicines and technical Guidance on the interpretation of the PIC/S Guide to GMP.

General description of this position’s role in the Department:
The role requires the quality oversight and preparation of some quality control documents.
These include, but are not limited to:

- Create incoming goods specifications as required.
- Review / check supporting documents prior release of incoming goods (e.g supplier CoA, CoC and TSE / BSE)
- Oversee receiving of incoming goods through reviewing receipt documents (e.g. Incoming Goods Checklist, Purchase Order and Delivery Documents)

- Some physical movement and counting of Pharmaceutical products as required (e.g. controlled substances)

The primary responsibilities & tasks of this position are:
- The receipt, testing, review, inspection, quarantine and disposition (release or rejection) of incoming materials for use in production, in accordance with company procedures.
- Ensue incoming materials received from approved suppliers / manufacturers.
- Periodic checking of status of starting materials, packaging materials and incoming goods until they have been released for production use or distribution
- Preparation of SOPs and / or WIs as required.
- Assist in scanning / Archiving incoming goods release documents.
- Assist in Internal and External audits. as required.

- Support the close out of Deviations, CAPA, change control, non-conforming related to incoming materials/products

- Quality Check of investigational medical products prior dispatching to clinical sites.
- Other duties as directed by the QC Team Leader.

Qualifications, Experience & Behavioural Competencies
The mandatory qualifications & experience:
- Bachelor of Science, Pharmacy or related Discipline
- Two years’ experience in cGMP pharmaceutical manufacturing facility, ideally in a Quality Control role.
- Proficient user of Microsoft Word and Excel

The desired qualifications & experience:
- Experience in Quality Control / Quality Assurance.

The behavioral competencies required for this position:
- Communication and responsiveness at all times
- Positive, ‘can-do’ attitude, embraces and ‘lives’ PCI’s Vision and Values
- Analytical thinker and solution finder/problem solver
- Collaborative, team player
- Objective and robust decision maker
- Excellent interpersonal, written and verbal communication
- Self-motivated and achievement orientated
- Trusting and trustworthy
- Conscientious and diligent
- Positive, embraces and responsive to change
Working Relationships
The position will report to the QC Team Leader and will work closely with the Project Managers, Warehouse employees and Production employees in order to ensure that all materials / products received and released for use comply to all requirements and are receipted and released in a timely manner to meet Production schedules.

Specific Physical, Psychological etc. Role & Work Environment
Requirements/Considerations
- Office / computer based
- Some manual handling may be required for movement of materials/product.

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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.