PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California. With global operations in Ireland, India, Singapore, Australia and the US, we serve 350 clients across more than 23 countries worldwide, providing cloud‑based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing, and metrology services.
Position
Quality Assurance, Validation Specialist
As a Quality Assurance, Validation Specialist you will support new Validation and Commissioning programs across the site and periodically review validated systems within the Drug Substance, Facilities, and laboratories to ensure ongoing compliance to cGLP and cGMP.
Key Responsibilities
Collaborate with project‑based teams, Validation, Microbiology, IT, Engineering utilities and other departments to provide QA support for commissioning, decommissioning and Validation projects across site.
Approve Validation Lifecycle documents and reports supporting the introduction of new laboratory and process equipment.
Approve Validation Lifecycle documents and reports supporting Temperature mapping, EMPQ and AVS studies.
Provide quality oversight of periodic review and equipment revalidation.
Review commissioning test scripts in real time and escalate issues promptly to CQV and QA leadership.
Support the Site Calibration program.
Act as QA point of contact for Cleaning Validation, WFI PQ, and PQ of process equipment (Filter Integrity, parts washers, Autoclaves and process Validation studies).
Champion the development of a Data Integrity Culture across site.
Apply working knowledge of GMP regulatory guidelines to interpret and provide quality guidance for validation activities in the drug substance and laboratory areas.
Perform any other tasks as directed by the QA Validation Lead.
Minimum Requirements
Minimum of a BSc Degree in a relevant Science (MSc preferable).
Minimum of 1 year Validation / CQV experience.
In order to excel in this role, you will more than likely have the following skills:
Desirable Experience
Experience and expertise in Chemistry, Chemical Engineering, Biological science, or Biotechnology in a Biopharmaceutical GMP setting.
Knowledge of cGMP Process & utility Quality Systems.
Knowledge of Deviation management, Change Management, and Risk Management.
Experience with KNEAT, Cleaning Validation, Environmental Monitoring, Filter Validation studies and Single‑use equipment.
Knowledge of regulatory guidelines supporting drug substance manufacturing (ICH, EU and FDA).
Strong technical writing skills.
Effective communication, presentation, and interpersonal skills for interfacing with all levels of colleagues and external customers.
Ability to work independently in a high‑paced team environment, meet deadlines, prioritize multiple projects, and collaborate with management locally and globally.
Seniority Level
Entry level
Employment Type
Full‑time
Job Function
Quality Assurance
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