QC Senior Analyst

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dundalk
• State/Province Louth
• 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:

• The QC Senior Analyst works as directed by the QCManager/QC Associate Director according to company safety policies, cGMP andcGLP. Ensure that QC team objectives are effectively achieved, consistentwithrequirements to ensure compliance,safety and reliable supply to our customers.
  
• Essential Functions and Responsibilities (Includes, butare not limited to) The QC Senior Analyst, is responsible for:
  
• Operating as part of the QC team performing the allocatedtesting and laboratory-based duties.
  
• Act as testing SME with QC department, participate in OOSinvestigations and supporting troubleshooting activities.
  
• Participate in QC Tier daily meetings and ensureeffective communication of testing progress, deviations, escalation ofpotential cGMP or compliance issues etc.
  
• Participate in writing/revising/ rolling out accurateoperational procedures, training materials and maintenance procedures forvarious Quality systems.
  
• Peer review of testing documentation and ensuring dataintegrity compliance and QC Right First Time KPIs are achieved.
  
• Support activities including general lab readiness, auditreadiness and audit participation, laboratory equipment qualification andanalytical method technical transfer, verification and validation.
  
• Candidate might be required to go on shifts, yet toconfirm. (It is 7 to 7 shift cycle)
  

Requirements

Responsibilities:

• Contributing to a continuous improvement environment andbringing problem solving and troubleshooting capabilities.
  
• Demonstrating a commitment to learning and personaldevelopment
  
• Degree qualification (Science/Quality/Technical orrelated)
  
• Laboratory experience, including sampling, testing,reporting in the biotechnology and/or pharmaceutical industry.
  
• 2-3 years of experience in QC Microbiology
  
• Motivation to be an inspiring member of a high performingteam and passion to build the future
  
• Desire to continuously learn, improve and develop.
  
• Flexible and self-motivated.
  
• Required to work on their own initiative in addition toworking as part of a team.
  
• Ability to manage multiple priorities and know when toescalate issues for resolution.
  
• Excellent time management and organizational skills.
  

Technical:

• Possess effective communication and presentation skills.
  
• Proficient with IT e.g. Microsoft office.
  
• Good critical thinking and problem solving skills.
  
• Good knowledge of cGMP, GLP, Quality Management Systems.