QC Microbiology Analyst

4 weeks ago

Dublin, 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

Who we are?

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.

Job Title: QC Microbiology Analyst

Role Description:

· The QC Microbiology Analyst role is a criticallyimportant activity to ensure efficient and effective compliant, qualification,and operation of the new strategic Drug Substance facility. This tremendousopportunity will be responsible for qualifying the Microbiology Quality Controllab and the verification of Microbiological analytical methods including butnot limited to cutting edge Rapid Microbiological Methods. This person will bekey in the layout of the lab testing flow to ensure the process is streamlinedand in line with lean principles.

· The candidate will provide support to otheranalysts within the lab area, including training and guidance on their area ofexpertise.

· The full QC analytical scope will incorporatemicro, raw materials, stability, and in-process.Innovation and advanced analytical methods(rapid ID technics, paperless lab, etc.) will allow the candidate challenge currentthinking in designing for the future. The candidate will have responsibilitiesin the qualification of methods.

Requirements

Role Functions:

· Perform and carry out a variety of routinemicrobiological analytical techniques including but not limited toenvironmental monitoring, WFI sampling & testing, growth promotion testing,TOC & Conductivity testing, in-process product testing, final producttesting such as bioburden and both Kinetic turbidimetric and MCS rapidendotoxin testing in compliance with GMP requirements.

· The motivation to be an inspiring member of ahigh performing team.

· The desire to continuously learn, improve and develop.

· Perform supportive activities for general labreadiness, laboratory equipment qualification and method qualifications.

· To integrate and complete all documentation ontime and be familiar with LIMS.

· Follow up-to-date analytical practices withreference to pharmacopoeias, specifications, regulations, and industry standards.

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

· Receive and manage samples that come into thelab for testing.

· Solution preparation, cleaning, routineequipment maintenance and system set-up

· Writing and update of SOPs

· 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 analysts on routineprocedures and practices.

· Order stock and receive laboratory supplies.

· Maintain data integrity and ensure compliancewith company SOPs, specifications, and cGMP regulations.

· Ensure that cGMP standards are maintained at alltimes.

· Delivery of area performance to meet or exceedperformance or quality goals.

· Promote and participate in the implementationand maintenance of the relevant safety programmes.

Participate and comply with the client QualityManagement System requirements.

· Responsible for driving a culture of ContinuousImprovement

Experience:

· 1-3 years industry experience with significantknowledge and experience working in a Microbiology Laboratory

· Experienced in testing as per the pharmacopeia’s.

· Working knowledge of QC Systems (eLogs,Electronic Lab Notebook, LIMS etc.)

Skills:

· Ability to respond to changing priorities.

· Strong organisational skills

· Good verbal and written communication skills

· Excellent troubleshooting and problem-solvingskills

· Ability to think logically and be proactive.

· Ability to work as part of a team and on owninitiative in a constructive manner

· Flexible and self-motivated

Qualifications & Education

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