Current jobs related to Quality System Specialist - Cambridge - Planet Pharma

  • Quality Systems Training and Documentation Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job Title: Quality Systems Training and Documentation SpecialistLocation: OnsiteScience: MicrobiomeJob Overview: As a Quality Systems Training and Documentation Specialist, you will be responsible for managing daily operations, training content via LMS, and documentation through EDMS across all GxP areas.Key Responsibilities:Manage ComplianceWire LMS,...

  • Quality Systems Training and Documentation Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job Title: Quality Systems Training and Documentation SpecialistJob Overview: Stratacuity is seeking a Quality Systems Training and Documentation Specialist to manage daily operations, training content via LMS, and documentation through EDMS across all GxP areas.Key Responsibilities:Manage ComplianceWire LMS to streamline training modules and roles for...

  • Quality Assurance Specialist

    5 days ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job Description:Draper Labs is seeking a Quality Assurance Specialist to join our Quality Audit team. As a Quality Assurance Specialist, you will be responsible for conducting process and product compliance audits related to Draper's Quality Management System (QMS) based on ISO 9001:2015 and AS9100 standards.Key Responsibilities:• Conduct process and...

  • Quality Systems and Compliance Specialist

    1 month ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job OverviewWe are seeking a highly skilled Quality Systems and Compliance Contractor to join our team at Stratacuity: Proven Scientific Placement. This role involves supporting Quality Systems and Compliance by managing product complaint handling, acting as document control backup, and assisting with regulatory inspection preparation.Key...

  • Quality Assurance Specialist

    1 month ago

    Cambridge, United States Voyager Therapeutics, Inc. Full time

    The Quality Assurance Specialist will actively contribute to the implementation and maintenance of the Quality Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing...

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time

    Job Title: Quality Assurance SpecialistVoyager Therapeutics, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Develop and maintain the Quality Systems Manual, ensuring...

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Apex Systems Full time

    Job Overview: We are seeking a Quality Assurance Specialist to develop and manage quality frameworks and documentation for research. The ideal candidate will collaborate with partners on standardization and provide training and guidance.Primary Job Responsibilities:* Standardize and streamline procedural documentation through collaboration* Implement a...

  • System Quality Assurance Specialist

    4 weeks ago

    Cambridge, Massachusetts, United States Draper Full time

    Job DescriptionAs a System Quality Engineer at Draper, you will play a critical role in ensuring the highest quality standards are met for our products. This position involves investigating and resolving issues, reviewing SOWs, RFPs, design plans, process procedures, test procedures, and manuals to understand the scope, requirements, and function of...

  • Quality Management Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States HyperLight Full time

    Quality Management SpecialistHyperLight is a venture-backed startup spun off from Harvard University in 2018 based on discoveries that enabled thin-film lithium niobate (TFLN) photonics. Our photonic integrated circuits offer exceptional performance unmatched by other materials and are manufactured at high volume and low cost. We design and manufacture...

  • Quality Systems and Compliance Specialist

    1 month ago

    Cambridge, United States Integrated Resources, Inc ( IRI ) Full time

    Duties: This position will support Quality Systems and Compliance functions in: •Management in product complaint handling including but not limited to: Intake of Product Complaints from the secured access mailbox Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates and Drug Safety & Pharmacovigilance Assist in...

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States RadNet Full time

    Job OverviewRadNet is seeking a highly skilled Quality Assurance Specialist to support the organization's Quality Management System. The successful candidate will be responsible for leading the document management process, complaint and CAPA management, and QMS training.Key ResponsibilitiesOwn and lead the document management process, including configuration...

  • Quality Assurance Specialist

    1 month ago

    Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time

    Job Title: Quality Assurance SpecialistVoyager Therapeutics, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Develop and maintain the Quality Systems Manual, ensuring it...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job Title: Incoming Materials, Senior QA SpecialistProclinical is seeking an experienced Incoming Materials, Senior QA Specialist to join our team in Cambridge, MA.Job Summary:The Incoming Materials, Senior QA Specialist will play a critical role in ensuring the quality and compliance of materials procured by our organization. This position requires a strong...

  • Quality Systems Director

    2 weeks ago

    Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full time

    MEDIPOST America, Inc. - Quality Systems LeadMEDIPOST America, Inc. is a leading cell therapy company dedicated to developing innovative treatments for degenerative diseases. We are seeking a highly experienced Quality Systems Lead to join our team and ensure the quality and regulatory compliance of our cell therapies from research to commercialization.Key...

  • Senior Scientist, Quality Control Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Garuda Therapeutics, Inc. Full time

    Quality Control Specialist OpportunityWe are seeking an experienced Quality Control Specialist to join our team at Garuda Therapeutics, Inc. in Cambridge, MA. This role will be responsible for supporting in-house QC method qualifications, performing QC testing, and managing authoring of quality systems records.Key Responsibilities:Support method transfer...

  • Quality Assurance Specialist

    6 days ago

    Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time

    The Quality Assurance Specialist will play a crucial role in ensuring the implementation and maintenance of the Quality Systems Manual at Voyager Therapeutics, Inc. This position will conduct GMP compliance audits as directed and have oversight of GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract...

  • Building Systems Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States JLL Full time

    Job SummaryWe are seeking a highly skilled Building Systems Specialist to join our team at JLL. As a key member of our facilities management team, you will be responsible for maintaining and operating the electrical and mechanical systems at our assigned buildings.Key ResponsibilitiesMaintain and update current CMMS information for all building operating...

  • Senior Quality Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Apex Systems Full time

    Job Overview: The Sr./Quality Specialist Audit Management is responsible for improving the Veeva system through testing, report development, and vendor management. This role requires a strong understanding of GxP and audit management principles, as well as experience with electronic systems like Veeva. The ideal candidate will have a bachelor's degree and be...

  • Electrical Systems Specialist

    2 weeks ago

    Cambridge, Ohio, United States Strike LLC Full time

    Job Summary:The Electrical Systems Specialist is responsible for the installation, maintenance, and repair of electrical systems in commercial settings. This role requires a high level of technical expertise and attention to detail, as well as the ability to work independently and as part of a team.Key Responsibilities: Reading and interpreting electrical...

  • Electrical Systems Specialist

    2 weeks ago

    Cambridge, Ohio, United States Strike LLC Full time

    Job Summary:The Electrical Systems Specialist is responsible for designing, installing, and maintaining electrical systems in commercial settings. This role requires a high level of technical expertise and attention to detail to ensure the safe and efficient operation of electrical systems.Key Responsibilities:Reading and interpreting electrical blueprints...

Quality System Specialist

2 months ago

Cambridge, United States Planet Pharma Full time

Responsibilities:

The Quality Systems Contractor will work to support the implementation of process improvements and workflow optimizations within Document Control and Quality Systems.

Summary of Key Responsibilities:

  • Support updates to Veeva meta-data, including review of existing configuration and making necessary changes required for system integrations.
  • Provide document processing support, including review of controlled GxP documentation for compliance with GDocP standards and internal processes.
  • Provide customer support with Veeva Quality Systems issues.
  • Support other process improvement initiatives as required.
  • Manage Global Quality Systems SOP revisions.

Requirements:

  • Bachelor’s Degree (BA/BS) and 3-4 years’ experience in an FDA regulated environment or similar experience preferred.
  • Prior system administration experience required, with administration of Veeva Quality Suite preferred.
  • Strong understanding of GxP Regulatory Requirements around Document Control and Training.
  • Understanding of GxP Regulatory Requirements around Quality Management Systems.
  • Self-directed and ability to independently complete projects with an eye for detail.
  • Strong interpersonal and organization skills .
  • Excellent computer skills including MS Word, Excel and Powerpoint. Advanced formatting skills within MS Word required.
  • Project management skills.