Job Title: Manufacturing Specialist
Location: New Albany, Ohio (On-Site)
Job Summary: Our team is seeking a proactive and detail-oriented professional to own and manage quality records at a pivotal manufacturing site. This role is integral to ensuring compliance with quality and regulatory standards, supporting our mission in the biotech sector.
Responsibilities:
- Oversee quality records including deviations, CAPAs, and change control to ensure they comply with regulatory requirements.
- Lead investigations of deviations and enact preventive actions while collaborating with cross-functional teams.
- Create and present quality record summaries to senior management for review and decision-making.
- Serve as the main point of contact for quality records at the New Albany site, liaising with external supply and technical teams.
Required:
- 4+ years of experience in a role focused on quality record ownership in the biotech or medical device industry.
- Hands-on proficiency with quality management systems like Veeva or TrackWise.
- Experience in dealing with secondary packaging and devices.
- Strong skills in root cause analysis and supplier defect investigations.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy