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, pharmaceutical contract manufacturing professionals, and metrology services to our clients.
Role Overview
An exciting opportunity for a QC Analyst to join the QC In Process Control team, based in a recently 5S certified analytical laboratory.
Your role will provide exposure across both Drug Substance and Drug Product manufacturing in a fast paced, highly compliant GMP environment.
The QC In Process team delivers comprehensive in process analytical and microbiological testing, supporting manufacturing operations across the site, as well as testing of incoming raw materials and packaging materials to support downstream pack line activities.
Due to the critical, around the clock nature of in‑process testing, you will be part of a 4‑cycle shift team supporting continuous manufacturing operations.
The team is high performing and team‑based, where colleagues are flexible, multi‑skilled, and empowered to make decisions while maintaining exceptionally high standards of quality, compliance, and safety.
Your role requires high initiative, energy, motivation, strong organisational skills, and the ability to thrive in a dynamic manufacturing environment.
Role Responsibilities
Reporting to the QC Team Lead, you will be responsible for supporting internal customers by delivering high‑quality, compliant test results in accordance with GMP standards.
Perform primary review of QC raw data and trend results.
Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies.
Draft and update QC Standard Operating Procedures (SOPs).
Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise.
Evaluate analytical and microbiological results against defined acceptance criteria.
Conduct and document laboratory investigations through to completion.
Maintain the laboratory in a constant state of audit and inspection readiness.
Interact directly with regulatory agency inspectors during audits and inspections.
Interface with other functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required.
Other duties as assigned.
Desired Skills and Attributes
Excellent written and verbal communication skills.
Strong customer focus and personal accountability for speed, quality, and accuracy of delivery.
Self‑motivated with the ability to work under pressure in a fast‑paced environment.
Team oriented, with active participation in team development and continuous improvement, including standard work and 5S.
Demonstrated success in achieving goals as part of a high‑performing team in a growing organization.
Proven adaptability and flexibility to support an evolving operational environment.
Education and Experience
BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience; or MSc with 3+ years of relevant cGMP laboratory experience.
Shift Pattern: 4‑cycle.
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