Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
Overview:
- We have an immediate opportunity for a sample management technician to join our Quality Operation Laboratory. You will operate as part of the QC team performing the allocated testing and laboratory-based duties and although it is preferable that Analysts have Immunoassay and cell culture experience, we are open to considering applicants that fulfil the duties as detailed below.
- This team is expanding, and we will consider you!
- The role is a day role starting 0700 to 1530.
- Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
What you will do:
- Receive, log, label, track and manage biological, environmental and manufacturing samples in accordance with site procedures and GMP requirements.
- Maintain sample chain of custody and ensure sample integrity throughout receipt, storage, distribution and disposal activities.
- Coordinate sample distribution to QC laboratories to support testing schedules and ensure timely product release.
- Manage sample inventory within laboratory information management systems (LIMS) and other tracking systems, ensuring accurate and contemporaneous documentation.
- Monitor sample storage locations, environmental conditions and retention inventories to ensure compliance with established procedures.
- Work as directed by the Sample Management Lead / Manager in accordance with Company safety policies, cGMP and GDP requirements.
- Drive compliance with Global policies, procedures, guidelines and regulatory requirements in the performance of all day-to-day activities.
- Ensure all Quality Systems within the department are adhered to on a daily basis.
- Support the timely receipt, processing and dispatch of samples to internal laboratories and external testing facilities where required.
- Ensure timely completion of all sample management documentation, data entry and record reviews.
- Participate in investigations relating to sample discrepancies, excursions, non-conformances and deviations.
- Generate and review sample management metrics and trend data to support operational performance and continuous improvement initiatives.
- Participate in QC Tier 1 daily meetings and ensure effective communication of sample volumes, priorities, issues and risks.
- Perform peer review of sample management records to ensure data integrity and Right First Time principles are maintained.
- Support laboratory audits and inspections by maintaining inspection-ready documentation and records.
- Drive continuous improvement initiatives and participate in root cause investigations using tools such as 5 Whys, Fishbone Diagrams and FMEA.
- Support management of laboratory consumables, sample containers and associated inventory where required.
- May be required to perform other duties as assigned.
- Bachelor's Degree or higher preferred; ideally in a Science, Biotechnology, Pharmaceutical or related discipline.
- Experience working in a GMP-regulated pharmaceutical, biotechnology or laboratory environment.
- Knowledge of cGMP, GDP and laboratory quality systems.
- Experience using LIMS, sample tracking systems or electronic inventory management systems.
- Strong organisational and planning skills with the ability to manage high sample volumes and competing priorities.
- Excellent attention to detail and commitment to data integrity principles.
- Proficiency in Microsoft Office and job-related computer applications.
- Experience writing reports, procedures and quality documentation is desirable.
- Understanding of deviation management, investigations and change control processes.
- Knowledge of Lean Six Sigma methodologies is advantageous.
- Strong communication and stakeholder management skills.
- Ability to work effectively both independently and as part of a cross-functional team.
- Demonstrated commitment to continuous improvement and operational excellence.
- High personal integrity, credibility, energy and flexibility.
- Willingness to support the team and maintain a strong customer-focused approach.