QC Microbiology Analyst

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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 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 candidate will provide support to other analysts within the lab area including training and guidance on their area of expertise.

The full QC analytical scope will incorporate micro raw materials stability and inprocess. Innovation and advanced analytical methods (rapid ID technics paperless lab etc.) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in the qualification of methods.

Requirements

Role Functions:

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 inprocess product testing final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.

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.

To integrate and complete all documentation on time and be familiar with LIMS.

Follow uptodate 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 setup

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 followup 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 client Quality Management System requirements.

Responsible for driving a culture of Continuous Improvement

Experience:

13 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:

Ability to respond to changing priorities.

Strong organisational skills

Good verbal and written communication skills

Excellent troubleshooting and problemsolving 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 selfmotivated

Qualifications & Education

Bachelor s Degree qualification (Science/Quality/Technical)

Masters preferred.

Preference Lean Six Sigma

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