QA Specialist
Madison, Wisconsin, United States of America
Full Time
13 hours ago
Key skills
Risk ManagementChange ManagementCommunication
About this role
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 and adaptable Quality Assurance Specialist to join our team! The QA Specialist plays a critical role in driving successful completion of operational tasks, performing quality reviews, and providing guidance to various departments to ensure adherence to regulatory requirements and industry best practices.
- Support tactical QA operations by assessing and reviewing floor activities against cGMPs for real-time observation, issue identification/resolution, and proper documentation.
- Ensure adherence to SOPs, change control, CAPA/deviation management, risk management, and compliance with FDA/EU regulatory standards.
- Provide guidance to GMP areas (Manufacturing, QC, etc.) to ensure compliance with all applicable regulations.
- Oversee change management system for minor and major classified change controls.
- Identify, classify, and report deviations; support remediation and CAPA activities.
- Ensure timely closure of investigations and resolution of issues before process release.
- Collaborate with cross-functional teams to determine root cause and implement preventative/corrective actions.
- Perform technical review of documentation during and post-execution of cGMP activities.
- Communicate with clients, vendors, and external services to resolve investigations and ensure compliance.
- Participate in inspection readiness activities and regulatory inspections.
- Support safety programs and audits.
- Additional duties as required.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related scientific or technical discipline.
- Experience working in a GMP‑regulated pharmaceutical, biotechnology, or life sciences environment.
- Working knowledge of cGMP, FDA regulations, and applicable global GxP standards.
- Experience with quality systems such as deviations, CAPA, change control, and documentation management.
- Strong root cause analysis, problem‑solving, and analytical skills.
- Ability to work cross‑functionally and communicate effectively with technical and non‑technical stakeholders.
- Strong written and verbal communication skills with the ability to produce clear, compliant documentation.
- Must be authorized to work in the U.S.
- No C2C at this time.