QC Bioanalytical Analyst

3 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Corporation Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

About PSC Biotech Ltd

Who we are?

PSC Biotech is aleading Biotech Consultancy firm founded in 1996, headquartered in Pomona,California, USA, with Global operations in Ireland, India, Singapore, Australiaand the US, serving 350 clients in more than 23 countries worldwide. We providecloud-based software solutions for Quality Management and RegulatoryInspections, pharmaceuticals contract manufacturing professionals, and metrologyservices to our clients.

'Take your Career to anew Level'

PSC Biotech disruptsthe conventional consultancy model by aligning our EVP as one of the uniqueselling point which includes the opportunity to work with the most talentedcohort of like-minded professionals operating in the Pharma/ BiotechIndustry. We offer a permanent contract of employment givingexposure of working in Top Pharmaceutical client sites in a diverse-culturalwork setting.

Employee ValueProposition

Employees are the"heartbeat" of PSC Biotech, we provide unparalleled empowering careerdevelopment though Learning & Development in-house training mentorshipthrough constant guidance to facilitate career progression. We believe increating high performing teams that can exceed our client's expectations withregards to quality of all scalable and business unit deliverables, stayingunder budget and ensuring timelines for our deliverables are being met.

Overview:

An amazing opportunity has arisen for a QC BioanalyticalAnalyst.

Requirements

Role Functions:

· Perform and carry out a variety of routineanalytical techniques including but not limited to DNA PCR and Bioassay ELISAtesting in compliance with GMP requirements.

· Follow up-to-date practices with reference topharmacopoeias, specifications, regulations and industry standards.

· Support the laboratory testing schedule toachieve an efficient QC system.

· Receive and manage samples that come into thelab for stability, in-process, and release testing.

· Reagent preparation, cleaning, and routineequipment maintenance.

· Maintain good housekeeping and hygiene withinthe laboratory.

· 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 compliancewith company SOPs, specifications and cGMP regulations.

· Ensure that cGMP standards are always maintained.

· 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 set in their areaof expertise that adds value to the business; ideally in a manufacturing,preferably in a GMP setting.

· Experience and critical skills in the area ofexpertise that add value to the business, ideally bioassay and DNA tests.

· Knowledge of regulatory/ code requirements toIrish, European and International Codes, Standards and Practices.

· Knowledge of cGMP & Laboratory QualitySystems.

· Effective communication, presentation, andinterpersonal skills, to interface effectively with all levels of colleaguesand with external customers in a team orientated manner.

Qualifications & Education:

· Qualification in Science/ChemicalEngineering/Biological Engineering

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