PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are hiring an experienced Quality Assurance Specialist to provide QA oversight and support for our pharmaceutical manufacturing clients. This individual will serve as a key quality representative, ensuring compliance with GMP regulations, regulatory requirements, and internal quality standards while supporting manufacturing, quality control, validation, engineering, and lifecycle project activities.
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Ensure compliance with FDA, EMA, ICH, and global regulatory requirements, as well as cGMP and company quality standards.
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Provide comprehensive QA oversight Provide QA within aseptic manufacturing, sterile processing, and biologics production activities.
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Review and approve quality documents including deviations, CAPAs, change controls, investigations, risk assessments, and validation documentation. Review and assess manufacturing records, batch documentation, and quality events to ensure regulatory compliance and product quality.
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Support internal and external audits, supplier audits, regulatory inspections, and quality management system activities.
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Partner with manufacturing, technical operations, quality control, and regulatory affairs teams to drive quality and compliance initiatives, proactively identify compliance risks, and implement effective solutions.
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Provide quality support and governance throughout the engineering project lifecycle, ensuring projects meet GMP, quality, and validation requirements throughout execution and implementation. Review and approve commissioning, qualification, validation, and engineering deliverables.
