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.