PSC Biotech is a life sciences consultancy that provides professional services and related support to help regulated healthcare and biotech companies develop, validate, manufacture, and distribute products in compliance with global regulatory standards. Its offerings include quality assurance, validation, commissioning, qualification, regulatory support, and managed services for pharmaceutical, biotechnology, medical device, and other highly regulated industries.

Products & services

Commissioning, Qualification, and Validation (CQV) CQV services for facilities, utilities, equipment, computerized systems, manufacturing processes, cleaning, and analytical test methods across the project lifecycle.
Computer System Validation and Computer System Assurance (CSV/CSA) Services Validation and assurance services for computerized systems, software, data integrity, and regulatory compliance, including QMS, ERP, LIMS, MES, and clinical systems.
Quality Assurance and Compliance Services GxP quality assurance and compliance support covering change control, risk management, deviations, CAPA, quality agreements, inspections, training, and validation review.
Auditing Services Supplier, laboratory, quality, regulatory, data integrity, and computerized-system audits, including gap assessments, risk assessments, and pre-approval inspection preparation.
Metrology and Calibration Services On-site and laboratory calibration, instrument qualification, thermal mapping, environmental monitoring, and calibration-program management for regulated operations.
Regulatory Affairs Services Regulatory strategy and submission support for life science companies interacting with FDA, EPA, OSHA, USDA, EU, and other regulatory bodies.

Leadership

John Clapham Founder, President & CEO

Seniority mix

Entry & junior 1 role
Mid-level 0 roles
Senior 5 roles
Lead & principal 0 roles
Manager & above 0 roles

Based on 6 open roles

Where they hire

Pomona, CA 3 roles
York, PA 2 roles
Columbia, MD 1 role

Based on 6 roles with a listed city

Work at PSC Biotech.

Open roles at PSC Biotech

Subscribe to Career Resources.

Your cookie choices