What are the responsibilities and job description for the Quality Systems Engineer position at Real Soft Inc?
Job Title: Quality Systems Engineer
Location: Massachusetts (Onsite / Fixed Office)
Work Schedule: Monday to Friday, 8 Hours
Employment Type: W-2 Contract
Job Summary:
Seeking an experienced Quality Systems Engineer / Analyst to support GMP biotechnology operations. This role will act as a hands-on quality partner for manufacturing, laboratory, and technical teams, ensuring timely and compliant completion of quality records in the electronic Quality Management System (eQMS).
Key Responsibilities:
- Partner with SMEs to create, review, and route change control records in eQMS
- Support teams in opening, writing, and closing deviation records
- Ensure change descriptions, impact assessments, and implementation plans meet GMP requirements
- Track timelines for change controls and deviations to avoid aging records
- Assist QC and analytical teams with OOS / OOT investigations documentation
- Manage controlled documents through review, approval, and release workflow in eQMS (Veeva Vault preferred)
- Guide SMEs on quality processes and eQMS workflows
- Identify and escalate quality issues or recurring trends to management
- Support audit readiness by ensuring records are accurate, complete, and on time
- Participate in continuous improvement initiatives within Quality Systems
Required Skills / Qualifications:
- Experience in GMP biotech / pharmaceutical environment
- Strong knowledge of Quality Systems processes
- Hands-on experience with Change Control, Deviations, CAPA, OOS, OOT
- Experience using eQMS systems (Veeva Vault preferred)
- Strong documentation, writing, and communication skills
- Ability to collaborate with cross-functional teams
- Strong attention to detail and timeline management
Preferred Background:
- Biotechnology / Pharma manufacturing experience
- Audit readiness / compliance support experience
- Continuous improvement mindset