Product Quality Specialist supporting quality, testing, documentation, and commercialization of algal omega - 3 products at Mara Renewables. Collaborating across Quality, Regulatory, Operations, and Commercial teams in hybrid Dartmouth role.
About the role
- Business Capability Specialist responsible for managing Deviations, CAPAs, and Planned Events in Pharma Quality. Ensuring compliance and system health in a highly regulated environment.
Responsibilities
- Serve as the Technical Subject Matter Expert for SAP S/4HANA and BRH systems
- Own the lifecycle of Deviations, CAPAs, and Planned Events
- Support the execution of IT Change Requests and ensure CSV compliance
- Monitor system health to resolve technical bottlenecks
- Maintain audit readiness and collaborate with IT and Business Process Owners
Requirements
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
- 5+ years of hands-on experience in a heavily regulated GxP environment (Pharma, Biotech, or MedTech)
- Deep experience within SAP (preferably S/4HANA) and Quality Systems (e.g., Veeva Vault Quality / BRH)
- Strong understanding of regulatory requirements (e.g., GMP Annex 11)
- Proficiency in technical investigations and CAPA plans
Benefits
- Embraced for unique qualities
- Open dialogue and genuine connections
- Valued and respected for individuality
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