What are the responsibilities and job description for the Senior Quality Associate position at Skills Alliance?
Position: Senior Quality Associate
Location: Indiana, USA
The Company:
A growing CDMO organization focused on the GMP production of biologics and advanced therapies. The site supports clinical and commercial manufacturing for global partners, ensuring high-quality products and strict adherence to regulatory requirements.
Position Overview:
The Senior Quality Associate will provide hands-on QA support for manufacturing operations, ensuring compliance with GMP standards and quality systems. This role is independent and operationally focused, supporting deviations, change controls, CAPAs, and media fill/qualification activities while maintaining rigorous oversight of the production environment.
Key Responsibilities:
- Support GMP manufacturing operations from a QA perspective, ensuring compliance with internal and external standards.
- Review and manage deviations, CAPAs, change controls, and other quality documentation.
- Participate in media fill, qualification, and process verification activities.
- Collaborate with manufacturing teams to ensure adherence to quality requirements and GMP practices.
- Contribute to audits, inspections, and internal quality reviews.
- Ensure accurate and timely documentation of QA activities in accordance with GMP.
Candidate Profile:
- Bachelor’s degree or higher in a scientific or technical discipline.
- 6 years of experience in a CDMO or Bio/Pharma environment.
- Strong hands-on QA experience supporting GMP manufacturing operations.
- Knowledge of deviations, CAPAs, change control, and media fill/qualification processes.
- Strong attention to detail, organizational skills, and ability to work independently.
- Onsite, full-time availability.
I look forward to receiving your application! 🎁