QC Microbiology Analyst-Shift

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

Employees are the “heartbeat” of PSC Biotech, we provide
unparalleled empowering career development though Learning & Development
in-house training mentorship through constant guidance to facilitate career
progression. We believe in creating high performing teams that can exceed our
client’s expectations with regards to quality of all scalable and business unit
deliverables, staying under budget and ensuring timelines for our deliverables
are being met.

• The QC Microbiology Analyst role is a critically
  important activity, ensuring efficient and effective compliant design,
  construction, qualification, and operation of the new strategic Biotech Drug
  Substance facility in Swords. This position will be responsible for qualifying
  the Microbiology Quality Control lab and the transfer of Microbiological
  analytical methods including but not limited to cutting edge Rapid
  Microbiological Methods. This person will be key in the layout of the lab
  testing flow to ensure the process is streamlined and in line with lean
  principles. Additional development opportunities within the micro and chemistry
  lab 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 candidate
  will be the key talent in analytical Microbiology techniques and in current
  Pharmacopeial methods.
  
• The facility will utilize the latest innovations in
  technology and automation to. The candidate will work with a high performing
  cross functional team of talent sourced from across the biotechnology industry.
  Together, the team will build the future of Biotech through a Quality culture
  that delivers unconstrained supply, Right First Time to our patients through an
  inspired team.
  
• The candidate will be actively supported and encouraged
  to continue their development and knowledge build, incorporating areas to
  support their future development and ability to continuously improve in their
  current role.
  
• The candidate will provide support to other analysts
  within the lab area, including training and guidance on their area of
  expertise.
  
• The full analytical scope of QC will incorporate
  microbiology, mycoplasma (DNA) analytics, analytical chemistry, bioassay, raw
  materials, stability and in-process testing. Advanced analytical methods (rapid
  ID techniques, paperless lab, etc) will allow the successful candidate to work
  in a innovative and stimulating environment which encourages communication and
  ideas for the future. The candidate will have responsibilities in analytical
  transfer and qualification of methods.
  
  

Requirements

Role Functions:

• The motivation to be an inspiring member of a high
  performing 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 routine
  microbiological analytical techniques including but not limited to
  environmental monitoring, WFI testing, growth promotion testing, In-process
  product testing, Final product testing such as bioburden and both Kinetic
  turbidmetric and MCS rapid endotoxin testing in compliance with GMP
  requirements.
  
• To integrate and complete all documention on time and be
  familiar with LIMS.
  
• To train and be trained in the use of Rapid microbiology
  techniques including but not limited to endotoxin testing, water bioburden
  testing, EM testing, absence of bioburden testing and identification testing.
  
• Follow up-to-date analytical practices with reference to
  pharmacopoeias, specifications, regulations and industry standards.
  
• To update SOP’s and write protocols as required.
  
• 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 GLP 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.
  
• Assist in training new QC Analysts on routine procedures
  and practices.
  
• 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.
  
• Delivery of area performance to meet or exceed
  performance or quality goals.
  
• Promote and participate in the implementation and
  maintenance of the relevant safety programmes.
  
• Participate and Comply with the Quality Management System
  requirements.
  
• Responsible for driving a culture of Continuous
  Improvement by deploying Six Sigma tools.
  
• This position will be on days initially but shift work
  will 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 expertise
  that add value to the business; ideally analytical microbiology, in a GMP
  setting.
  
• Knowledge of cGMP.
  
• Report, standards, policy writing skills required.
  
• Lean Six Sigma Methodology experience.
  
• Understand the specific responsibilities of all
  departments as they relate to one’s own department, understanding the business
  processes one’s department supports.
  
• 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:

• Third Level science qualification (Microbiology is
  preferred).