Senior Quality Specialist

Title: Senior Quality Specialist
Location: Boston, MA
Rate: $45 $50/hr on W2 max

Position Overview

Seeking a Senior Quality Specialist to provide QA oversight for Commissioning, Qualification, and Validation (CQV) activities and quality initiatives at a GMP manufacturing facility in Boston. The role supports Quality Operations, Engineering, Manufacturing, Facilities, Utilities, and Laboratory Operations, ensuring compliance with cGMP and regulatory requirements.

Key Responsibilities

CQV & Quality Engineering

• Provide QA oversight for qualification and validation of facilities, equipment, and utilities.

• Review and approve validation strategies, protocols, IQ/OQ/PQ, process validation, and CQV documentation.

• Analyze validation data and support regulatory inspections and internal audits.

Quality Systems Management

• Independently author and manage deviations, change controls, CAPAs, and root cause investigations.

• Support quality event resolution, risk assessments, and quality-related decisions.

Operational QA Oversight

• Review and approve calibration activities, preventive maintenance records, eCRs, work orders, and instrument qualifications.

• Provide oversight for Environmental Monitoring (EM), Utilities Monitoring (UM), Veriteq temperature monitoring systems, and pest control programs.

• Support equipment/utilities trending and periodic reviews.

Cross-Functional Collaboration

• Partner with Engineering, Manufacturing, Facilities, Validation, and Quality Control teams.

• Support qualification protocol execution, capital projects, plant shutdowns, and site improvement initiatives.

Required Qualifications

• Master's degree in Life Sciences or equivalent with 5 7 years of relevant experience, or Bachelor's degree with 8 10 years of relevant experience.

• Experience in QA oversight of GMP manufacturing operations.

• Pharmaceutical drug product manufacturing experience; oral solid dosage preferred.

• Strong understanding of cGMP regulations, CMC requirements, quality systems, and compliance.

• Experience with equipment, facilities, and utilities qualification in a GMP environment.

• Hands-on experience leading change controls, deviations, investigations, RCA, and CAPA programs.

• TrackWise and Oracle experience preferred.

• Strong documentation, communication, problem-solving, and cross-functional collaboration skills.

Preferred Qualifications

• Cleaning validation and temperature-controlled equipment qualification experience.

• Knowledge of ASTM E2500, CSV/GAMP, and related validation standards.

• Experience with Quality Engineering, digital innovation, and data-driven quality systems.

• Ability to independently manage priorities, identify issues, and escalate appropriately.

Salary
The hourly rate for this position is $45 $50/hr on W2, depending on experience and qualifications. Benefits
Eligible employees may have access to benefits offered by Novozen Healthcare LLC in accordance with the applicable benefit plans and eligibility requirements. Equal Employment Opportunity
Novozen Healthcare LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law. Background Check
Background checks may be conducted in accordance with applicable law.