QC Bioanalytical 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

Overview:

QC Bioanalytical Analyst responsible for performing
analytical testing within the Biologics laboratory

Requirements

Role Functions:

• Perform and carry out a variety of routine analytical
  techniques including but not limited to HPLC, Compendials, UV, Raw
  Materials,  DNA PCR and Bioassay ELISA
  testing in compliance with GMP requirements.
  
• Follow up-to-date practices with reference to pharmacopoeias,
  specifications, regulations and industry standards.
  
• Support the laboratory testing schedule to achieve an
  efficient QC system.
  
• Receive and manage samples that come into the lab for
  stability, in-process and release testing.
  
• Reagent preparation, cleaning, and routine equipment
  maintenance.
  
• Maintain good housekeeping and hygiene within the
  laboratory.
  
• Calibrate and maintain all designated laboratory
  instruments.
  
• Participate in risk assessments, inspections, audits,
  incident investigations, etc. and implement and follow-up on corrective /
  preventative measures.
  
• Ensure training is current for all job functions
  performed.
  
• Order, stock and receive laboratory supplies.
  
• Maintain data integrity and ensure compliance with
  company SOPs, specifications and cGMP regulations.
  
• Ensure that cGMP standards are maintained at all times.
  
• Promote and participate the implementation and
  maintenance of the relevant safety programs.
  

Experience,
Knowledge & Skills:

• 1 - 5 years laboratory testing experience in the
  Pharmaceutical industry. 
  
• Relevant experience and skill sets in their area of
  expertise that adds value to the business; ideally in a manufacturing,
  preferably in a GMP setting.
  
• Experience and critical skills in the area of expertise
  that add value to the business; ideally bioassay and DNA tests.
  
• Knowledge of regulatory/ code requirements to Irish,
  European and International Codes, Standards and Practices.
  
• Knowledge of cGMP & Laboratory Quality Systems.
  
• Effective communication, presentation and interpersonal
  skills, to interface effectively with all levels of colleagues and with
  external customers in a team orientated manner.
  

Qualifications
& Education:

• Qualification in Science/Chemical Engineering/Biological
  Engineering