QA Specialist

PSC Biotech • North Coast, PR

1d

About The Position

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.

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.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Biochemistry, Microbiology, or related field.
• 5+ years of direct Quality Assurance experience within regulated pharmaceutical manufacturing environments.
• Proven experience within aseptic manufacturing.
• Extensive knowledge of FDA, EMA, ICH, and global GMP regulations.
• Experience managing and supporting deviations, CAPAs, change controls, investigations, and quality risk management activities.
• Strong understanding of Quality Control operations and laboratory compliance requirements.
• Experience overseeing commissioning, qualification, validation, and engineering lifecycle activities.
• Proven ability to work effectively across multiple functional areas and external manufacturing partners.
• Strong verbal and written communication skills.
• Must be authorized to work in the U.S.
• No C2C at this time.

Responsibilities

• Ensure compliance with FDA, EMA, ICH, and global regulatory requirements, as well as cGMP and company quality standards.
• Provide comprehensive QA oversight within aseptic manufacturing, sterile processing, and biologics production activities.
• 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.
• Support internal and external audits, supplier audits, regulatory inspections, and quality management system activities.
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior