QC Microbiology Lab

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 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 Lab

Job Description:

Under minimal supervision successful candidate would be responsible for one or more of the following activities in QC including microbiological testing method transfers sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their workday performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations as such some extended hours shift and weekend work may be necessary as required.

Requirements

Job duties are as follows but not limited to:

Endotoxin testing of water inprocess and drug product release samples

Bioburden testing of water & inprocess drug product samples

Sterility testing

Water sampling

Lab Support duties such as Biological Indicator testing Growth Promotion Media Preparation Identifications and Autoclave.

Writing technical reports

Perform analytical testing as a main priority with efficiency and accuracy.

With a high degree of technical flexibility work across diverse areas within the lab

Plan and perform multiple routine/ nonroutine methods and procedures with a large variety of assays.

Report evaluate archive trend and approve analytical data.

Troubleshoot solve problems and communicate with stakeholders.

Initiate and/or implement changes in controlled documents.

Participate in audits initiatives and projects that may be departmental or organizational in scope.

Write protocols and perform assay validation.

Introduce new techniques to the lab including method transfers reports validations and protocols.

Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

Review and Approve lab results.

May participate in lab investigations.

May provide technical guidance.

May train others.

May contribute to regulatory filings.

May represent the department/organization on various teams.

May interact with outside resources.

Basic Qualifications:

Bachelor s degree in a science discipline

Biopharmaceutical QC experience in a microbiology lab

Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.