QC Microbiology Analyst-Shift

• 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 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 Microbiology Analyst role is a criticallyimportant activity, ensuring efficient and effective compliant design,construction, qualification, and operation of the new strategic Biotech DrugSubstance facility in Swords. This position will be responsible for qualifyingthe Microbiology Quality Control lab and the transfer of Microbiologicalanalytical methods including but not limited to cutting edge RapidMicrobiological Methods. This person will be key in the layout of the labtesting flow to ensure the process is streamlined and in line with leanprinciples. Additional development opportunities within the micro and chemistrylab will be strongly considered to recognize the tremendous value of knowledge/ experience gained by the candidate during the project phases.
  
• To maximize the development opportunity, the candidatewill be the key talent in analytical Microbiology techniques and in currentPharmacopeial methods.
  
• The facility will utilize the latest innovations intechnology and automation to. The candidate will work with a high performingcross functional team of talent sourced from across the biotechnology industry.Together, the team will build the future of Biotech through a Quality culturethat delivers unconstrained supply, Right First Time to our patients through aninspired team.
  
• The candidate will be actively supported and encouragedto continue their development and knowledge build, incorporating areas tosupport their future development and ability to continuously improve in theircurrent role.
  
• The candidate will provide support to other analystswithin the lab area, including training and guidance on their area ofexpertise.
  
• The full analytical scope of QC will incorporatemicrobiology, mycoplasma (DNA) analytics, analytical chemistry, bioassay, rawmaterials, stability and in-process testing. Advanced analytical methods (rapidID techniques, paperless lab, etc) will allow the successful candidate to workin a innovative and stimulating environment which encourages communication andideas for the future. The candidate will have responsibilities in analyticaltransfer and qualification of methods.
  

Requirements

Role Functions:

• The motivation to be an inspiring member of a highperforming team.
  
• The desire to continuously learn, improve and develop.
  
• Perform supporting activities for general lab readiness,laboratory equipment qualification and method transfers.
  
• Perform and carry out a variety of routinemicrobiological analytical techniques including but not limited toenvironmental monitoring, WFI testing, growth promotion testing, In-processproduct testing, Final product testing such as bioburden and both Kineticturbidmetric and MCS rapid endotoxin testing in compliance with GMPrequirements.
  
• To integrate and complete all documention on time and befamiliar with LIMS.
  
• To train and be trained in the use of Rapid microbiologytechniques including but not limited to endotoxin testing, water bioburdentesting, EM testing, absence of bioburden testing and identification testing.
  
• Follow up-to-date analytical practices with reference topharmacopoeias, specifications, regulations and industry standards.
  
• To update SOP's and write protocols as required.
  
• 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 GLP within the 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.
  
• Assist in training new QC Analysts on routine proceduresand practices.
  
• 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.
  
• Delivery of area performance to meet or exceedperformance or quality goals.
  
• Promote and participate in the implementation andmaintenance of the relevant safety programmes.
  
• Participate and Comply with the Quality Management Systemrequirements.
  
• Responsible for driving a culture of ContinuousImprovement by deploying Six Sigma tools.
  
• This position will be on days initially but shift workwill be required,4 Days On/ 4 Days Off. 12 Hour days.
  

Experience, Knowledge & Skills:

• 1 to 2 years' relevant experience.
  
• Experience and critical skills in the area of expertisethat add value to the business; ideally analytical microbiology, in a GMPsetting.
  
• Knowledge of cGMP.
  
• Understand the specific responsibilities of alldepartments as they relate to one's own department, understanding the businessprocesses one's department supports.
  
• Effective communication, presentation and interpersonalskills, to interface effectively with all levels of colleagues and withexternal customers in a team orientated manner.
  

Qualifications & Education:

• Third Level science qualification (Microbiology ispreferred).