About PSC Biotech
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 points 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 through 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
Join a dynamic and growing team focused on the analysis of biologics and vaccines in a state‑of‑the‑art Quality Operations laboratory. The site plays a strategic role in manufacturing and testing leading biologic and vaccine products. This position supports laboratory expansion, analytical method transfers, validation, and commercial testing activities.
The role operates on a 2‑cycle and 4‑cycle shift pattern, with occasional travel required for training.
Requirements
Key Responsibilities
Quality & Compliance
Work under the direction of the QC Manager in accordance with company safety policies, cGMP, and cGLP standards
Ensure compliance with global policies, regulatory requirements, and quality guidelines
Execute all activities in line with Good Manufacturing Practices (GMP)
Laboratory Operations
Perform routine and non‑routine laboratory testing to support product release
Operate as part of the QC team, executing assigned analytical tasks
Participate in daily QC Tier 1 meetings, communicating progress, issues, and deviations
Analytical Testing
Conduct testing using advanced analytical techniques, including:
HPLC (HIC, CE, IEX, HP‑SEC)
Capillary Electrophoresis
Compendial methods
Ensure accurate documentation and data integrity in all testing activities
Documentation & Systems
Write, revise, and implement SOPs, training materials, and maintenance procedures
Perform peer review of testing documentation to ensure Right First Time (RFT) performance
Utilize systems such as LIMS for laboratory data management
Investigations & Audits
Support and participate in Out of Specification (OOS) investigations
Assist in audit and inspection readiness activities
Act as an auditee during internal and external audits
Continuous Improvement
Drive process improvements using tools such as:
FMEA
Fishbone diagrams
5 Whys
Conduct root cause analysis for system failures and equipment issues
Promote a strong safety and compliance culture
Required Qualifications
Bachelor’s degree (or higher) in Analytical Chemistry, Biochemistry, or a related discipline
Experience & Skills
2–3 years of experience in a pharmaceutical QC laboratory
Strong hands‑on experience with HPLC systems and associated software
Knowledge of:
cGMP and GLP regulations
Quality Management Systems
Laboratory operations and compliance
Core Competencies
Analytical Method Transfer
GMP Compliance & Laboratory Practices
Laboratory Analytical Techniques
Laboratory Information Management System (LIMS)
OOS & Laboratory Investigations
Quality Control Operations
Sterility Testing
Technical Documentation & Procedures
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