QC Bioanalytical Analyst

4 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Dublin
  • State/Province Dublin
  • 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 Careerto 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 ValueProposition

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:

QC Bioanalytical Analyst responsible for performinganalytical testing within the Biologics laboratory

Requirements

Role Functions:

  • Perform and carry out a variety of routine analyticaltechniques including but not limited to HPLC, Compendials, UV, RawMaterials,DNA PCR and Bioassay ELISAtesting 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 anefficient QC system.
  • Receive and manage samples that come into the lab forstability, in-process and release testing.
  • Reagent preparation, cleaning, and routine equipmentmaintenance.
  • Maintain good housekeeping and hygiene within thelaboratory.
  • Calibrate and maintain all designated laboratoryinstruments.
  • 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 functionsperformed.
  • Order, stock and receive laboratory supplies.
  • Maintain data integrity and ensure compliance withcompany SOPs, specifications and cGMP regulations.
  • Ensure that cGMP standards are maintained at all times.
  • Promote and participate the implementation andmaintenance of the relevant safety programs.

Experience,Knowledge & Skills:

  • 1 - 5 years laboratory testing experience in thePharmaceutical industry.
  • Relevant experience and skill sets in their area ofexpertise that adds value to the business; ideally in a manufacturing,preferably in a GMP setting.
  • Experience and critical skills in the area of expertisethat 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 interpersonalskills, to interface effectively with all levels of colleagues and withexternal customers in a team orientated manner.

Qualifications& Education:

  • Qualification in Science/Chemical Engineering/BiologicalEngineering
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