Sample Management Technician

PSC Biotech Corporation; Carlow; Presencial; EUR 30.000 - 45.000; Jornada completa

Descripción de la vacante

PSC Biotech Corporation, a leading Biotech consultancy with global operations, is hiring a Sample Management Technician for our Quality Operation Laboratory in Carlow. You will join the QC team performing allocated testing and laboratory duties; immunoassay/cell culture experience is preferred but candidates fulfilling the duties will be considered.

The role follows a day shift 0700 to 1530, working within GMP-compliant processes, maintaining sample custody, and supporting timely product release

Formación

• Bachelor's Degree or higher in science, biotechnology, pharmaceutical or related discipline.
• Experience in a GMP-regulated pharmaceutical/biotech lab environment.
• Knowledge of cGMP, GDP and laboratory quality systems.
• Experience using LIMS or electronic sample tracking systems.
• Strong organizational skills with ability to manage high sample volumes.
• Proficiency in Microsoft Office and related applications.
• Experience writing reports and quality documentation.
• Understanding of deviation management, investigations and change control.
• Lean Six Sigma knowledge is advantageous.
• Strong communication and stakeholder management skills.

Responsabilidades

• Receive, log, label, track and manage samples per GMP site procedures.
• Maintain sample custody and integrity through receipt, storage, distribution and disposal.
• Coordinate sample distribution to QC laboratories to support testing schedules.
• Manage sample inventory in LIMS and other tracking systems.
• Monitor storage locations and retention inventories for compliance.
• Support the Sample Management Lead/Manager and follow safety, cGMP and GDP requirements.
• Drive compliance with Global policies and regulatory requirements in daily activities.
• Ensure Quality Systems adherence within the department.
• Support timely receipt, processing and dispatch of samples.
• Participate in investigations related to discrepancies and deviations.
• Generate and review sample management metrics and trends.
• Participate in QC Tier 1 daily meetings and communicate priorities and risks.
• Peer review sample management records to ensure data integrity.
• Support audits and inspections with inspection-ready documentation.
• Contribute to continuous improvement and root cause investigations.
• Handle laboratory consumables and inventory.
• Perform other duties as assigned.

Conocimientos

Attention to detail

Organizational skills

Communication

Teamwork

Continuous improvement

Customer focus

Team support

Educación

Bachelor's degree or higher in science/biotech/pharma

Herramientas

LIMS

Microsoft Office

Inventory management systems

Descripción del empleo

• Industry Pharma/Biotech/Clinical Research
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Overview:

• We have an immediate opportunity for a sample managementtechnician to join our Quality Operation Laboratory. You will operate as partof the QC team performing the allocated testing and laboratory-based duties andalthough it is preferable that Analysts have Immunoassay and cell cultureexperience, we are open to considering applicants that fulfil the duties asdetailed 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 materialinside our products is manufactured, processed, tested, packaged, stored anddistributed aligned with our incredibly high standards of quality and meets allregulatory requirements.Partnering acrossour internal manufacturing facilities, external contract manufacturers andsuppliers we create an interdependent global manufacturing network committed todeliver a compliant, reliable supply to customers and patients on time, everytime, across the globe.
  

Requirements

What you will do:

• Receive, log, label, track and manage biological,environmental and manufacturing samples in accordance with site procedures andGMP requirements.
  
• Maintain sample chain of custody and ensure sampleintegrity throughout receipt, storage, distribution and disposal activities.
  
• Coordinate sample distribution to QC laboratories tosupport testing schedules and ensure timely product release.
  
• Manage sample inventory within laboratory informationmanagement systems (LIMS) and other tracking systems, ensuring accurate andcontemporaneous documentation.
  
• Monitor sample storage locations, environmentalconditions and retention inventories to ensure compliance with establishedprocedures.
  
• Work as directed by the Sample Management Lead / Managerin 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-dayactivities.
  
• Ensure all Quality Systems within the department areadhered to on a daily basis.
  
• Support the timely receipt, processing and dispatch ofsamples to internal laboratories and external testing facilities whererequired.
  
• Ensure timely completion of all sample managementdocumentation, data entry and record reviews.
  
• Participate in investigations relating to samplediscrepancies, excursions, non-conformances and deviations.
  
• Generate and review sample management metrics and trenddata to support operational performance and continuous improvement initiatives.
  
• Participate in QC Tier 1 daily meetings and ensureeffective communication of sample volumes, priorities, issues and risks.
  
• Perform peer review of sample management records toensure data integrity and Right First Time principles are maintained.
  
• Support laboratory audits and inspections by maintaininginspection-ready documentation and records.
  
• Drive continuous improvement initiatives and participatein root cause investigations using tools such as 5 Whys, Fishbone Diagrams andFMEA.
  
• Support management of laboratory consumables, samplecontainers 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 aScience, 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 orelectronic inventory management systems.
  
• Strong organisational and planning skills with theability to manage high sample volumes and competing priorities.
  
• Excellent attention to detail and commitment to dataintegrity principles.
  
• Proficiency in Microsoft Office and job-related computerapplications.
  
• Experience writing reports, procedures and qualitydocumentation is desirable.
  
• Understanding of deviation management, investigations andchange control processes.
  
• Knowledge of Lean Six Sigma methodologies isadvantageous.
  
• Strong communication and stakeholder management skills.
  
• Ability to work effectively both independently and aspart of a cross-functional team.
  
• Demonstrated commitment to continuous improvement andoperational excellence.
  
• High personal integrity, credibility, energy andflexibility.
  
• Willingness to support the team and maintain a strongcustomer-focused approach.