QC Microbiology Analyst-Shift

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 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.

Overview :

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 . 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, analystical 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,   7-7 days only. 4 on 4 off.

Experience, Knowledge & Skills :

Qualifications & Education :

Requirements

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. Third Level science qualification (Microbiology is preferred). Knowledge of cGMP. Report, standards, policy writing skills required.