Job Description
About the job
Title: Quality Systems Specialist
Location: Greater Waltham Area, MA (Hybrid – Onsite Tuesday–Thursday)
Employment Type: Contract
Duration: 6+ months
Status: Accepting Candidates
About the Role
We’re hiring a Quality Systems Specialist to support global Quality Systems operations for a leading biopharmaceutical manufacturing organization. This role is heavily focused on documentation, training, system governance, and validation support within a regulated GxP environment.
Key Responsibilities
- Support Quality Systems operations to ensure compliance with SOPs and regulatory requirements (FDA, EMA, ICH)
- Assist with governance of Quality System applications, including harmonization across sites
- Gather and document system requirements through workshops and meetings with SMEs and process owners
- Participate in user forums to collect, prioritize, and triage enhancement requests and system issues
- Initiate, manage, and complete change controls, including required documentation
- Maintain systems in a validated state (user access reviews, change management, deviation & CAPA support)
- Support investigation, escalation, and resolution of system-related issues
- Execute validation activities, including requirements gathering, validation planning, IQ/OQ support, test scripts, execution, discrepancy management, and validation reporting
- Provide system administration, user onboarding, and training support
Qualifications
- Experience supporting Quality Systems in a biopharma / pharmaceutical / life sciences environment
- Strong background in documentation-heavy roles (SOPs, training materials, change controls)
- Hands-on experience with change management, deviations, and CAPA
- Familiarity with validated systems and GxP compliance
- Exposure to QMS tools (e.g., TrackWise, Veeva, MasterControl) is strongly preferred
- Strong communication skills and ability to work cross-functionally
Compensation (MA Pay Transparency)
- Estimated hourly range: $40–$50/hr (W-2)
- Final rate within the posted range will be based on skills, experience, and interview results