Sample Management Technician

About PSC Biotech

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.
  

Requirements

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.
  

What skills you will need:

• 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.