Quality Engineering and Validation Consultant

Hours: 40 hours/week
Duration: 6 months (possible extension) Local candidates preferred – onsite in Boston, Monday–Friday ----------------------------------------------------------------------------------------------

The Quality Engineering and Validation Consultant is recognized as an expert internally in the principles and application of quality assurance and compliance. This position coordinates GMP activities in support of clinical and commercial Drug Product manufacture. This position reports to Associate Director GMP Quality - Cell & Gene. This is an onsite Monday through Friday position.

REQUIRED EXPERIENCE:

• Experience providing QA support and oversight of GMP manufacturing operations and capital projects
• Aseptic processing
• Experience successfully leading event investigations, Root Cause Analysis and CAPA
• Experience with network-based applications such as Veeva, Nuvolo, Viewlinc
• Master’s degree with 3-5 years of relevant work experience, or bachelor’s degree in engineering, scientific or allied health field with minimum 8 years of relevant work experience, or relevant comparable background.

REQUIRED SKILLS:
Leadership Skills

• Collaboration / Teamwork / Conflict Management
• The ability to thrive in a high throughput environment
• Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.
• Ability to independently collaborate on cross-functional teams and represent the Quality unit
• Ability to communicate effectively across all organizational levels
• Ability to evaluate quality matters and make decisions utilizing risk-based approach

KEY RESPONSIBILITIES:

• As part of the GMP Operational Quality group primarily responsible with providing quality oversight and support to Cell and Gene Therapy operations and capital projects in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of validation, analytical laboratory, materials management, and facility/engineering groups.
• Provide QA support of change controls, validation protocols, risk assessments, GMP investigations and CAPAs.
• Responsible for identifying risks and communicating gaps for GMP process/systems
• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications
• Review and approval of trending programs (equipment, facility, utilities, etc.)
• Support EM and Routine testing of facilities and utilities and control programs (BMS/EMS, pest control, etc.)