What are the responsibilities and job description for the Sr. Quality Assurance Associate position at Real Soft Inc?
Sr. Quality Assurance Associate / Quality Operations Engineer
Location: Boston, MA (Onsite)
Industry: Biotechnology / Pharmaceutical
Summary
Seeking a Quality Assurance professional with 4 years of GMP experience to support clinical-stage biotech operations. Responsible for quality oversight of CDMOs/CTLs, batch record review, regulatory submission review, source data verification, and management of quality systems.
Key Responsibilities
- Review batch records, testing protocols, reports, and stability documentation.
- Support batch disposition, deviations, CAPAs, change controls, and investigations.
- Review regulatory submissions and perform source data verification.
- Support document control and eQMS workflows (TrackWise/Veeva Vault).
- Ensure compliance with FDA, ICH, EU, and GxP regulations.
- Assist with audit readiness and continuous quality improvement initiatives.
Required Skills
- 4 years in Quality Assurance within Pharmaceutical/Biotechnology.
- Strong GMP/GxP compliance experience.
- Experience with Deviations, CAPA, Change Control, and Document Control.
- TrackWise and/or Veeva Vault experience.
- Regulatory documentation review and data verification.
- Strong communication, analytical, and problem-solving skills.
Education
- Bachelor's degree in Life Sciences, Biotechnology, Chemistry, or related scientific field.