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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.
The QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliant, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for qualifying the Microbiology Quality Control lab and the verification 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.
The facility will utilize the latest innovations in technology and automation and latest in analytical technics. The candidate will work with a high performing cross functional team of talent sourced from across and the biotechnology industry. Together, the team will build the future of biologics through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team.
The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.
Role Functions
The motivation to be an inspiring member of a high performing team
The desire to continuously learn, improve and develop
Perform supportive activities for general lab readiness, laboratory equipment qualification and method qualifications
Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements
To integrate and complete all documentation 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, bioburden testing, EM testing, absence of contamination testing and identification testing
Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards
Support the laboratory testing schedule to achieve an efficient QC system
Receive and manage samples that come into the lab for testing
Solution preparation, cleaning, routine equipment maintenance and system set-up
Writing and update of SOPs
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 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
Experience:
1-3 years industry experience with significant knowledge 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:
Strong organisational skills
Good verbal and written communication skills
Excellent troubleshooting and problem-solving skills
Good attention to detail
Ability to think logically and be proactive
Ability to work as part of a team and on own initiative in a constructive manner
Flexible and self-motivated
Full Time