What are the responsibilities and job description for the Quality Assurance Specialist - Supplier Management position at RoslinCT?
Transforming the world of cell and gene therapy, RoslinCT is a leading contract development and manufacturing organization. We thrive on collaboration, dedication, and expertise to create groundbreaking therapies that make a difference in people's lives.
We foster an environment where our team members can grow professionally, develop their skills, and contribute to the advancement of revolutionary treatments.
We adhere to a set of core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. Our employees enjoy a flexible work environment, competitive benefits package, and emphasis on work-life balance, making us the best place for talented individuals to thrive.
The Senior Supplier Quality Assurance Specialist plays a vital role in ensuring compliance with FDA regulations and internal SOPs. Responsibilities include managing supplier documentation, monitoring supplier performance, and leading corrective actions based on audits.
This position offers opportunities for growth and impact:
- Support the supplier qualification program by onboarding new suppliers, maintaining documentation, and scheduling audits.
- Collaborate with Supply Chain and Purchasing/Procurement teams to ensure seamless supplier interactions.
- Manage the Supplier Change Notification Program, reviewing notifications and escalating potential issues.
- Monitor the SCAR/Corrective Action Program, initiating activities and following up on completion.
To excel in this role, you should possess:
- A highly organized approach to task execution.
- A focus on accuracy and precision in results.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Effective problem-solving and communication skills.
We seek candidates with:
- B.S. in science, engineering, biochemistry, or related discipline, or equivalent experience and training.
- A minimum of 5 years of experience in a regulated environment, preferably in biopharmaceuticals or similar fields.
- Knowledge of supplier quality management, including assessments, audits, and corrective actions.
- Familiarity with US and EU cGMP regulations and guidance.
- Experience with internal or supplier audits and strong communication skills.
