Quality Assurance Lead III

1 week ago


Waltham, Massachusetts, United States Pyramid Consulting Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Lead III to join our team at Pyramid Consulting, Inc. in Waltham, MA. This is a 12+ months contract opportunity with long-term potential.

Key Responsibilities:

  • Reviews and approves Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities.
  • Provides Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
  • Reviews and Approves Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments.
  • Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
  • Write, revise and perform QA review and approval on SOPs, forms, WI, and other document types.
  • Provides iShift support for GMID and BOM approval.
  • Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested.
  • Assume additional responsibilities as assigned.

Key Requirements and Technology Experience:

  • Skills; Master Manufacturing Records, Stability Protocols, Quality Assurance.
  • Bachelor's and/or 8+ years of relevant experience
  • Minimum 5 years of experience in Quality
  • Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment.
  • Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants.
  • Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
  • Preferred experience with outsourced manufacturing and testing operations
  • Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.


  • Waltham, Massachusetts, United States Pyramid Consulting, Inc Full time

    Job Title: Quality Assurance Lead IIIJob Summary: We are seeking a highly skilled Quality Assurance Lead III to provide quality oversight and guidance to resolve compliance issues for drug substance, bulk drug product, drug product, and clinical materials.Key Responsibilities:Provide quality oversight and guidance to resolve compliance issues for drug...


  • Waltham, Massachusetts, United States Aequor Technologies Full time

    At Aequor Technologies, we are seeking a highly skilled Quality Assurance Lead III to join our team. The successful candidate will provide quality oversight and guidance to resolve compliance issues for various drug substances, bulk drug products, and clinical materials used in clinical trials.The ideal candidate will have a minimum of 5 years of experience...


  • Waltham, Massachusetts, United States Aequor Technologies Full time

    Job Summary:We are seeking a Quality Assurance Lead III to join our team at Aequor Technologies. In this role, you will provide quality oversight and guidance to resolve compliance issues for drug substance, bulk drug product, drug product, and clinical materials used in clinical trials.You will perform QA review and approval on SOPs, forms, WI, and other...


  • Waltham, Massachusetts, United States PSG Global Solutions Careers Full time

    Job DescriptionAt PSG Global Solutions Careers, we're seeking a highly skilled Quality Assurance Associate III to join our team. As a key member of our Quality Assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our global operations.Responsibilities:Support quality oversight across GPV GBUs on PV...


  • Waltham, Massachusetts, United States Pyramid Consulting Full time

    Job Title: Quality Assurance Lead IIIJob Summary: We are seeking a highly skilled Quality Assurance Lead III to provide quality oversight and guidance to resolve compliance issues for drug substance, bulk drug product, drug product, and clinical materials.Key Responsibilities:* Provides quality oversight and guidance to resolve compliance issues for drug...


  • Waltham, Massachusetts, United States ZoomInfo Full time

    Job Title: Quality Assurance Automation Engineer IIIAbout the Role:We are seeking a highly skilled Quality Assurance Automation Engineer III to join our team at ZoomInfo. As a key member of our Quality Assurance team, you will be responsible for designing and implementing test solutions to measure and validate the infrastructure and functionality of our...


  • Waltham, Massachusetts, United States Boston Scientific Full time

    About the RoleWe are seeking a highly skilled Design Assurance Engineer III to join our team at Boston Scientific. As a key member of our EP division, you will play a critical role in ensuring the safety, quality, and compliance of our cardiac mapping and ablation systems.ResponsibilitiesWork collaboratively with cross-functional teams to ensure project...


  • Waltham, Massachusetts, United States Boston Scientific Full time

    About the Role:We are seeking a highly skilled Design Assurance Engineer III to join our team at Boston Scientific. As a key member of our cross-functional team, you will be responsible for ensuring the safety, quality, and compliance of our cardiac mapping and ablation systems.Your primary responsibilities will include:Leading the determination and...


  • Waltham, Massachusetts, United States Lyra Therapeutics Full time

    Job Title: Manager/Sr. Manager GCP Clinical Quality AssuranceLyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge technology...


  • Waltham, Massachusetts, United States RPM ReSearch Full time

    Job SummaryThe Director of Quality Assurance is responsible for overseeing all aspects of the Quality Assurance function, including the development, implementation, and maintenance of an effective Quality Management System. This includes ensuring compliance with relevant regulations and standards, such as FDA and EMA guidelines.The ideal candidate will have...


  • Waltham, Massachusetts, United States Lyra Therapeutics Full time

    Job Title: Manager/Sr. Manager GCP Clinical Quality AssuranceLyra Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing innovative, integrated drug and delivery solutions for the localized treatment of patients with chronic diseases. Our mission is to improve patient outcomes and quality of life through cutting-edge research...


  • Waltham, Massachusetts, United States TScan Therapeutics Full time

    Job Title: Senior Director of Quality AssuranceAbout the Role:TScan Therapeutics is seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team and ensure the highest standards of quality in our GMP operations. As a key member of our Technical Operations and Quality team, you will be responsible for developing and...


  • Waltham, Massachusetts, United States TScan Therapeutics Full time

    Job Title: Senior Director of Quality AssuranceAbout the Role:TScan Therapeutics is seeking a highly experienced Senior Director of Quality Assurance to lead our Quality Assurance team and ensure the highest standards of quality in our GMP operations. As a key member of our Technical Operations and Quality team, you will be responsible for developing and...


  • Waltham, Massachusetts, United States RailWorks Full time

    Job Title: Quality Assurance ManagerRailWorks is seeking a highly skilled Quality Assurance Manager to oversee the quality control programs of construction projects. As a key member of our team, you will be responsible for ensuring that our work meets the highest standards of quality and safety.Key Responsibilities:Develop and implement quality control...


  • Waltham, Massachusetts, United States ElevateBio Full time

    Director of Quality Assurance OperationsElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to...


  • Waltham, Massachusetts, United States ElevateBio Full time

    Job Title: Director of Quality Assurance OperationsElevateBio is a technology-driven cell and gene therapy company that accelerates access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and...


  • Waltham, Massachusetts, United States ZoomInfo Full time

    Quality Assurance Automation SpecialistAs a Quality Assurance Automation Specialist at ZoomInfo, you will play a critical role in ensuring the quality and reliability of our directories. You will work within a scrum team to design and implement test solutions that measure and validate the infrastructure and functionality of our products.Key...


  • Waltham, Massachusetts, United States GQR Full time

    Job Title: Director, Clinical Quality Assurance, PharmacovigilanceJob Summary:GQR is seeking a highly experienced Director of Clinical Quality Assurance and Pharmacovigilance to lead our team in ensuring the highest standards of quality and safety in our pharmaceutical operations.Key Responsibilities:Develop and implement risk-based audit plans to ensure...


  • Waltham, Massachusetts, United States GForce Life Sciences Full time

    Quality Systems SpecialistHybrid Opportunity in Waltham, MA - Must be able to work on a W2At GForce Life Sciences, we are seeking a highly skilled Quality Systems Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring the integrity and compliance of our quality systems.Key Responsibilities:Collaborate with...


  • Waltham, Massachusetts, United States Advantage Technical Full time

    Job SummaryThe Quality Assurance Specialist will be responsible for supporting Global Quality Systems and their operations in ensuring compliance and fit for intended use per applicable global SOPs. This role will focus on the governance of Quality System applications, including harmonization of processes across sites.Key ResponsibilitiesEnsure the system is...