QC Sample Management Analyst

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:

Responsible for supporting the Quality Control Department
in the management of external sample shipments and retain sample management.
Support various administrative duties associated with sample management.
Ensuring that objectives are effectively achieved to, consistent with requirements
to ensure Compliance, safety and reliable supply to our customers. This is a
Day role based on site (Mon -Fri)

Requirements

Role Functions:

• Will act as point of contact for QC sample and retain
  management.
  
• Responsible for QC External sample management from
  receipt to shipment.
  
• Responsible for QC retain sample management from receipt
  to disposal.
  
• Knowledge and understanding of current Good Manufacturing
  Practices (cGMP) related to the QC Laboratory and ability to identify gaps in
  processes or systems.
  
• Proficient with using Microsoft Office applications
  (Outlook, Excel, Word, and PowerPoint).
  
• Proficient with Lab management software system (LIMS).
  
• Prepare documents and coordinate Sample movement within
  the Warehouse area.
  
• Review eLogs and/ or LIMs to align physical quantities of
  samples in freezers/refrigerators/lean lifts and sample cages.
  
• Take ownership of processes related to sample handling
  e.g. oversight of freezers/refrigerator clean schedule.
  
• Perform or support sample management related
  non -conformance investigations.
  
• Supports Internal and Regulatory Audits.
  
• Format, write and deliver necessary documentation in line
  with Global Policies, Procedures and Guidelines, regulatory requirements.
  
• Support continuous improvement by active participation
  and engagement with laboratory team during investigations and subsequent
  corrective actions.
  
• Ensure timely completion of all assigned documents to
  meet site metric requirements.
  
• Work collaboratively to drive a safe and compliant
  culture
  
• Participate in QC daily tier meetings and ensure
  effective communication of assigned tasks/projects.
  
• May be required to perform other duties as assigned.
  

Experience, Knowledge & Skills

Technical:

• Proficiency in Microsoft word, Office, excel and
  job -related computer applications required i.e. LIMS
  
• Knowledge of regulatory/code requirements to Irish,
  European and International Codes, Standards and Practices
  
• Understanding of Lean Six Sigma Methodology preferred
  

Business:

• Excellent communication, presentation and interpersonal
  skills, to interface effectively with all levels of colleagues and with
  external customers, in a team orientated manner
  
• Ability to work with teams and escalate issues to
  management in a proactive manner.
  
• Planning and scheduling skills Customer service
  
• Goal/results orientated.
  
• Training skills
  
• Effective time management and multi -tasking skills
  
• Proven organizational skills.
  
• Excellent attention to detail
  
• Self -motivated
  
• Flexible approach
  

Qualifications & Education

• Third Level qualification preferred, ideally in a related
  discipline.
  
• Experience and/or a particular skill set in their area of
  expertise that adds value to the Business, preferably GMP setting.