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 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 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 in-process.  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, in-process 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 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 client 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:

·         Ability to respond to changing priorities.

·         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

Qualifications & Education

·         Bachelor’s Degree qualification
(Science/Quality/Technical)

·         Masters preferred.

·         Preference Lean Six Sigma