* 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 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 points, 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, providing exposure to work 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 through learning & development, in-house training, mentorship, and constant guidance to facilitate career progression. We aim to create high-performing teams that exceed our client’s expectations regarding quality, staying under budget, and meeting timelines.
Overview
* The QC Microbiology Analyst role is crucial in ensuring compliant design, construction, qualification, and operation of the new biotech drug substance facility in Swords. Responsibilities include qualifying the microbiology QC lab and transferring microbiological analytical methods, including rapid microbiological methods. The role involves designing the lab testing flow for efficiency and lean principles. Opportunities for development within microbiology and chemistry labs are available.
* The candidate will be a key talent in analytical microbiology techniques and pharmacopeial methods.
* The facility will utilize the latest technology and automation. The candidate will work with a high-performing, cross-functional team from the biotech industry, building the future of biotech through a quality culture focused on delivering right first time to patients.
* The candidate will be supported in continuous development and knowledge building, with opportunities to expand their expertise.
* The role includes supporting other analysts, training, and guidance within the lab.
* The analytical scope includes microbiology, mycoplasma (DNA) analytics, analytical chemistry, bioassay, raw materials, stability, and in-process testing. Advanced methods like rapid ID techniques and paperless labs will be used. Responsibilities include analytical transfer and qualification of methods.
Shift Pattern
* The role will start on days for training and then shift to 7-7 days (4 on, 4 off).
* Day shift: Monday – Friday.
* Shift pattern: 4 days on / 4 days off, 12-hour days.
Requirements
* Motivation to be part of a high-performing team.
* Desire to learn, improve, and develop.
* Support activities for lab readiness, equipment qualification, and method transfers.
* Perform routine microbiological techniques including environmental monitoring, WFI testing, growth promotion testing, in-process and final product testing (bioburden, kinetic turbidimetric, MCS endotoxin testing) in GMP compliance.
* Complete documentation timely and be familiar with LIMS.
* Train in rapid microbiology techniques.
* Follow current analytical practices per pharmacopoeias, regulations, and standards.
* Update SOPs and write protocols as needed.
* Support testing schedules and manage samples.
* Reagent preparation, equipment maintenance, and housekeeping.
* Calibrate and maintain lab instruments.
* Participate in risk assessments, audits, incident investigations, and implement corrective actions.
* Ensure training is current and assist in training new analysts.
* Order and manage lab supplies.
* Maintain data integrity and compliance with SOPs, specifications, and cGMP regulations.
* Maintain cGMP standards at all times.
* Drive performance to meet or exceed quality goals.
* Participate in safety programs and quality management system requirements.
* Promote continuous improvement using Six Sigma tools.
* This position will start on days, with eventual shift work required.
Qualifications
To excel, you will likely have:
* 1-2 years of relevant experience.
* Experience and skills in microbiology, especially in a GMP environment.
* Knowledge of cGMP.
* Understanding of departmental responsibilities and business processes.
* Effective communication, presentation, and interpersonal skills.
* Third-level science qualification, preferably in Microbiology.
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