Quality Control Technician

PSC Biotech Corporation; Carlow; On-site; EUR 32,000 - 42,000; Full time

Job summary

PSC Biotech Corporation in Carlow, Ireland, is seeking a Technician, Quality Control to join our vaccine and biologics-focused QC team. You will ensure CGMP/GDP compliance in day-to-day activities, manage sample lifecycle with GLIMS, and collaborate across Manufacturing, QA, and External Quality teams.

The role emphasizes data integrity, ALCOA principles, and continuous improvement to meet site goals and regulatory standards.

Qualifications

• Experience with a LIMS (GLIMS experience is an advantage).
• Strong communicator, comfortable working with stakeholders at all levels.
• Able to prioritise and deliver against competing deadlines.
• Collaborative and able to communicate effectively across functions.
• Committed to continuous improvement and operational excellence.

Responsibilities

• Liaise with the QC Leads to resolve quality related queries where required.
• Ensure that adequate processes and procedures are inplace and followed for all Quality activities.
• Provide support to the relevant support functions to ensure manufacturing and release activities, in compliance with applicable procedures, our Company’s Global Policies and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
• Develop and maintain effective cross-functional relationships with other departments and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Support business critical projects related to the Quality Department.

Skills

LIMS experience

Communication

Prioritisation

Collaboration

Continuous improvement

Education

Leaving Certificate

Tools

GLIMS

Job description

• 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.

Technician, Quality Control

• Comply with and execute CGMP/GDP in the performance ofday-to-day business activities.
  
• Ensure data integrity principles: Attributable, Legible,Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records anddata in day-to-day business activities.
  
• Attend and successfully complete applicable CGMPtraining.
  
• Escalate any potential violation of CGMP and/or otherconcerns which may affect the safety, efficacy, quality, or purity of human health products.
  
• Work collaboratively to ensure a safe and compliantculture
  
• Participate in driving a high performing s inclusiveculture, stimulating personal growth s development may be required to performother duties as assigned.
  
• Coordinate the end-to-end sample lifecycle in GLIMS:receipt, logging, processing, distribution and traceability through todisposal.
  
• Prioritise and schedule sample workload to meet timelines
  
• Coordinate shipment of samples to external contractlaboratories and sister sites
  
• Log retain samples in accordance with retain samplemanagement programme
  
• Ensure day-to-day activities meet GMP and regulatorystandards
  
• Contribute to root cause investigations using structuredproblem-solving tools
  
• Identify and deliver continuous improvement projects thatimprove efficiency and reliability
  
• Partner with Manufacturing, QC, Quality Assurance,External Quality and other stakeholders to meet site goals
  

Requirements

About You:

• Experience with a LIMS (GLIMS experience is an advantage)
  
• Strong communicator, comfortable working withstakeholders at all levels
  
• Able to prioritise and deliver against competingdeadlines
  
• Collaborative and able to communicate effectively acrossfunctions
  
• Committed to continuous improvement and operationalexcellence
  

Responsible for activities including some or all ofthe following and any other tasks as required:

Quality:

• Liaise with the QC Leads to resolve quality relatedqueries where required
  
• Ensure that adequate processes and procedures are inplace and followed for all Quality activities.
  
• Provide support to the relevant support functions toensure manufacturing and release
  
• activities, in compliance with applicable procedures, ourCompany’s Global Policies and Guidelines, regulatory requirements and currentGood Manufacturing Practices (cGMP).
  
• Develop and maintain effective cross-functionalrelationships with other departments and support functions to ensure that theprocess for the manufacturing, testing and release of vaccine and biologicproducts are in compliance with cGMP and the associated regulatoryrequirements.
  
• Identify and support compliance initiatives to improvecompliance status and overall operational efficiency for batch release at thesite.
  
• Support business critical projects related to the QualityDepartment.
  

Delivery:

• Responds to standard requests and communication processesto allow the flow of appropriate information between departments.
  
• Use MPS principles and tools to identify and supportcontinuous improvement by active participation to ensure quality systems andwork practices are effective, efficient and ensure compliance and overalloperational efficiency for batch and material release at the site whererequired.
  
• Sign approved job description.
  

Site Business Area Support:

• Support in resolving routine potential quality issues.
  
• Provide quality support of controls and procedures forthe end to end material and product lifecycle where applicable.
  
• Assist team members to support thequalification/validation, technical transfers, and commercial operations at thefacility where required.
  

Quality Control:

• Support the Sample Management team members completing dayto day activities, as applicable.
  

Compliance Responsibilities:

• Ensure compliance to regulatory requirements.
  
• Assist team members with tasks relating to SOP's,Deviations and other documents as necessary for the Quality and Manufacturingdepartments where required.
  
• Contribute to effective writing/revising/rolling out ofaccurate operational procedures, training materials and maintenance proceduresfor various Quality related systems.
  

Other:

• Participate in training programs as required.
  

Typical Minimum Education:

• Leaving Certificate or other relevant experience.