GMP Operational Quality Specialist

5 days ago


Boston, United States Hydrogen Group Full time

Location: Boston, MA/Hybrid

Schedule: Standard Office Hours

Duration: 24-Month Contract

Pay Rate Range: $43.00/ph - $48.00/ph

The GMP Operational Quality Specialist operates independently to provide QA Analytical support for commercial product stability programs and performs routine QA Analytical tasks.

Key Responsibilities:

  • Conduct QA reviews of GMP data for commercial product stability.
  • Collaborate with internal and external partners to resolve quality issues.
  • Act as a Quality technical resource on cross-functional teams.
  • Oversee Root Cause Analysis (RCA), product impact assessments, and ensure appropriate corrective/preventive actions (CAPAs).
  • Support stability-related change control activities, including assessment, implementation, and closure.
  • Perform GMP document reviews (procedures, work instructions, specifications, methods, etc.).
  • Manage external stability program activities, including protocol and data review and study initiation.
  • Enforce Quality Agreements with external partners related to stability studies and data management.
  • Identify and implement continuous improvement efforts.
  • Assess risks and assist with risk mitigation plans.

Knowledge and Skills:

  • Strong understanding of cGMPs and global GMP requirements.
  • Familiarity with analytical techniques (e.g., HPLC, dissolution, GC, KF).
  • Experience working with Contract Manufacturing/Testing Organizations.
  • Ability to manage multiple projects in a fast-paced environment while ensuring quality and timeliness.
  • Excellent communication skills for cross-functional collaboration.
  • Competence in evaluating quality issues and making decisions based on technical expertise.
  • Knowledge of quality event investigations, RCA, and CAPA implementation.
  • Experience with change control assessment and electronic document management systems (e.g., LIMS, Veeva).

Preferred Qualifications:

  • Bachelor's degree in a scientific discipline (or equivalent) with 3-4 years of relevant experience.
  • Advanced knowledge of GMP regulations and guidelines (ICH, USP, etc.).
  • Background in analytical or manufacturing QA operations.
  • Proficiency in Root Cause Analysis tools, technical writing, and facilitation/problem-solving in regulated environments.



...



  • Boston, United States Vertex Full time

    Job DescriptionGeneral Summary:The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and...


  • boston, United States Hydrogen Group Full time

    Location: Boston, MA/HybridSchedule: Standard Office HoursDuration: 24-Month ContractPay Rate Range: $43.00/ph - $48.00/phThe GMP Operational Quality Specialist operates independently to provide QA Analytical support for commercial product stability programs and performs routine QA Analytical tasks.Key Responsibilities:Conduct QA reviews of GMP data for...


  • Boston, Massachusetts, United States Verve Therapeutics, Inc. Full time

    About Verve Therapeutics, Inc. Verve Therapeutics is a pioneering genetic medicines company transforming the treatment of cardiovascular disease. Company Overview At Verve Therapeutics, we are dedicated to solving the global health epidemic of cardiovascular disease. Our innovative approach involves developing gene editing medicines that have the potential...


  • Boston, United States Digital Prospectors Full time

    Position: Quality Operations Specialist Location: Boston, MA (Hybrid – 3 days onsite) Length: 2+ years Job Description: Our client is seeking a detail-oriented and independent Quality Operations Specialist to join a dynamic team supporting the Quality Assurance (QA) function for commercial product stability programs. In this role, you will provide QA...


  • Boston, United States Katalyst Healthcares and Life Sciences Full time

    Description:seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible for supporting...


  • Boston, United States Katalyst Healthcares and Life Sciences Full time

    Description:seeking a Quality Assurance Sr. Specialist for real time on the floor quality oversight and lot disposition of Small Molecule GMP manufacturing facility at Moderna Inc. This position will be based in our cGMP Small Molecule Manufacturing site in Cambridge, MA. The individual in this role will be part of a cohesive team responsible for supporting...


  • Boston, United States Vertex Pharmaceuticals Full time

    Job Description: The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. This position reports to Manager GMP Quality - Cell & Gene. Ideal candidate will have...

  • Lead GMP Tech

    2 days ago


    Boston, MA, United States Cushman & Wakefield Full time

    Job Title Lead GMP Tech Job Description Summary The Lead GMP Tech is responsible for maintaining and documenting specific Vertex GMP facility, manufacturing, and R&D lab equipment maintenance through its entire life cycle from installation through decommissioning. They work directly with the end users, vendors and Quality Assurance to support GMP API and...

  • Lead GMP Tech

    20 hours ago


    Boston, MA, United States C&W Services Full time

    Job Title : Lead GMP Tech Job Description Summary The Lead GMP Tech is responsible for maintaining and documenting specific Vertex GMP facility, manufacturing, and R&D lab equipment maintenance through its entire life cycle from installation through decommissioning. They work directly with the end users, vendors, and Quality Assurance to support GMP API and...


  • Boston, MA, United States Digital Prospectors Full time

    Position: Quality Operations Specialist Considering making an application for this job Check all the details in this job description, and then click on Apply. Location: Boston, MA (Hybrid - 3 days onsite) Length: 2+ years Job Description: Our client is seeking a detail-oriented and independent Quality Operations Specialist to join a dynamic team supporting...


  • Boston, MA, United States C&W Services Full time

    Job Title : GMP Inventory Project Support Job Description Summary Job Description Key Responsibilities: Properly check, purchase, and maintain spare parts inventory in stock rooms. Report regularly on standard inventory control metrics including inventory ordering and usage trend reporting. Develop/Maintain multi-site trackers for open orders, spare...


  • Boston, United States Aveo Pharmaceuticals Inc Full time

    JOB TITLE: Director, Quality Assurance DEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024JOB SUMMARY: The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture...


  • Boston, United States Page Mechanical Group, Inc. Full time

    JOB TITLE: Director, Quality AssuranceDEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024JOB SUMMARY:The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture...


  • Boston, United States Jobot Full time

    Job DescriptionJob DescriptionBonus + Equity + 401(k) + REMOTEThis Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $160,000 - $185,000 per yearA bit about us:We are a rapidly growing biotherapeutics company with an approved drug on the market, leveraging scientific...


  • Boston, Massachusetts, United States Aveo Pharmaceuticals Inc Full time

    • Develop and implement a robust Quality Management System ensuring outsourced GMP operations comply with regulations and industry standards.• Provide strategic direction and oversight of Quality Assurance activities across product development and commercialization.• Lead cross-functional initiatives promoting a culture of continuous improvement,...

  • MRI Quality Specialist

    3 months ago


    Boston, United States Boston Medical Center Full time

    POSITION SUMMARY: The MRI Quality Specialist is an integral member of the MRI department at Boston Medical Center. This technologist functions as a facilitator, coordinator, investigator, educator, quality specialist and MRI technologist. Working closely with the Manager of MRI services, the MRI Quality Specialist anticipates problems before they arise and...


  • Boston, MA, United States Vertex Pharmaceuticals Incorporated Full time

    Job Description The Manufacturing Operations Specialist, Training will assist with facilitating trainings, tracking metrics, and actively improving upon the training program at the Vertex Manufacturing Center. This trainer will need strong technical knowledge on either adherent or suspension cell culture. The incumbent will work in collaboration with drug...

  • IT Manager/CSV/GMP

    3 days ago


    Boston, United States Azzur Group Full time

    Senior Manager, Infrastructure Operations & Security (Contract/Hybrid*3 days per week in the Office) Senior Manager, Infrastructure Operations & Security (Temp to Perm) Reporting to: Associate Director, IT Operations, Infrastructure and Security Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear...


  • Boston, MA, United States Page Mechanical Group, Inc. Full time

    JOB TITLE: Director, Quality Assurance DEPARTMENT: Quality Assurance DATE PREPARED: September 10, 2024 JOB SUMMARY: The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP...


  • boston, United States Hydrogen Group Full time

    Inspection Readiness Manager Boston, MA/HybridSchedule: Standard Office HoursDuration: 6-month contractPay: $62-72/hr, depending on experiencePosition OverviewThe Quality Assurance Specialist is responsible for overseeing real-time inspection readiness activities supporting GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) quality...