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.
Summary:
We are seeking a highly skilled and motivated Quality Control Bioassay Specialist to join our Quality Control team on a fixed-term contract basis .This critical role will support key bioassay laboratory start-up activities and provide technical expertise to support quality control testing, method troubleshooting, method establishment, investigations, and capability building across the team.
The successful candidate will play an important role in helping establish the laboratories as a hub for specialised analytical testing, while ensuring compliance with cGMP and corporate regulations. This is a high-impact role within the Quality organisation, offering the opportunity to contribute directly to operational excellence and patient impact.
Key Responsibilities:
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Provide technical support for Quality Control testing activities, including:
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Method execution troubleshooting
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Method establishment
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Input into investigations
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Capability building in Biochemistry, Cell Biology, and Analytical methods
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Support the performance and optimisation of advanced assays requiring strong analytical and scientific understanding.
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Review, evaluate, and approve analytical testing data.
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Complete special project and protocol testing in a timely manner under direction of Project Leads and/or Area Leads.
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Use laboratory instrumentation and Global LIMS or other computerized systems to collect, record, and approve test data/results.
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Collaborate with laboratory and cross-functional teams to improve efficiency, solve problems, generate cost savings, and support new product introductions.
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Operate with minimal supervision and demonstrate sound judgment and accountability.
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Maintain the laboratory in a GMP-compliant state in accordance with EHS and 5S requirements.
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Prepare and update SOPs as required.
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Apply Lean principles, including 5S, simplification, and standard work, in daily activities.
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Ensure training requirements are current and support the training of others as needed.
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Coach and develop team members to build technical capability and support a high-performance culture.
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Support regulatory submissions, inspection readiness, health authority inspections, and responses to inspection observations.
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Contribute to audit readiness, laboratory equipment qualification, and analytical method transfer, verification, and validation.
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Support site metrics and KPI achievement, implementing countermeasures where required.
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Maintain data integrity and ensure compliance with company SOPs, specifications, FDA, cGMP, and other applicable regulations.
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Participate actively in inspections, GEMBAs, and Go-Sees.
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Promote a strong safety culture by identifying hazards, conducting risk assessments, and supporting continuous improvement in EHS practices.
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Act as a visible leader in safety, quality, and continuous improvement initiatives.
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Encourage innovation, problem solving, and real-time data-driven decision-making to improve the value stream.
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Perform other tasks as required.
What You’ll Bring:
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Degree in Science, Quality, or a related technical discipline.
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Minimum of 5 years’ experience in the biotechnology and/or pharmaceutical industry, preferably both.
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Strong technical knowledge of cell-based and cell biology methods, such as qPCR, as well as analytical methodologies.
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Strong understanding of GMP, ICH, USP, and global compendia regulations and guidance, particularly relating to analytical method development and validation.
