Current jobs related to Quality Systems Specialist - Cambridge - Randstad Life Sciences US

  • Quality Assurance Specialist

    2 weeks ago

    Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full time

    Job DescriptionAlphanumeric Systems Inc. is seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our dynamic team.Key Responsibilities:Quality Assurance Oversight: Ensure that our products meet both Local and Global quality standards by executing all activities following quality and regulatory standards and procedures.Quality...

  • Quality Assurance Specialist

    3 weeks ago

    Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full time

    Alphanumeric Systems Inc. is seeking a highly skilled and experienced Quality Assurance Specialist to join our dynamic team in Cambridge, MA. We partner with a leading client dedicated to improving lives through medical and pharmaceutical advancements. In this role, you will play a crucial part in ensuring that our products meet both local and global...

  • Quality Systems and Compliance

    2 days ago

    Cambridge, United States Proclinical Staffing Full time

    Quality Systems and Compliance - Contract - Cambridge, MAProclinical is seeking a dedicated and detail-oriented individual for the role of Quality Systems and Compliance Specialist. This is a contract position located in Cambridge, MA.Primary Responsibilities:This role will primarily focus on managing product complaint handling and supporting regulatory...

  • Quality Systems Specialist

    1 week ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job SummaryWe are seeking an experienced Quality Systems Contractor to join our team at Proclinical Staffing. As a Quality Systems Contractor, you will play a crucial role in supporting the implementation of process improvements and workflow optimizations within Document Control and Quality Systems.Key ResponsibilitiesProcess Improvement: Collaborate with...

  • Quality System Specialist

    3 weeks 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...

  • Quality System Specialist

    3 weeks 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...

  • Quality Systems Contractor

    4 weeks ago

    Cambridge, United States Proclinical Staffing Full time

    Quality Systems Coordinator - Contract - Cambridge MA Proclinical is seeking an experienced Quality Systems Contractor to join a dedicated team. Primary Responsibilities:The successful candidate will be required to support the implementation of process improvements and workflow optimizations within Document Control and Quality Systems. This role focuses on...

  • Quality Systems Contractor

    4 weeks ago

    Cambridge, United States Proclinical Staffing Full time

    Quality Systems Coordinator - Contract - Cambridge MA Proclinical is seeking an experienced Quality Systems Contractor to join a dedicated team. Primary Responsibilities:The successful candidate will be required to support the implementation of process improvements and workflow optimizations within Document Control and Quality Systems. This role focuses on...

  • Quality Assurance Specialist

    4 weeks ago

    Cambridge, Massachusetts, United States SPECTRAFORCE Full time

    Job Title: Quality Assurance Specialist - Quality SystemsLocation: RemoteDuration: Contract PositionThis position is a hybrid role with scheduled work hours Monday to Friday, 8:30 AM to 5:00 PM, requiring onsite presence based on project needs.Key Responsibilities:The Quality Assurance Specialist operates within the Quality Systems division and collaborates...

  • Quality Assurance Specialist

    4 days ago

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

    Job SummaryWe are seeking a highly skilled Quality Systems and Compliance Specialist to support our Quality Systems and Compliance functions. This role will be responsible for managing product complaints, regulatory inspection preparation, and document control.Key ResponsibilitiesManage product complaints, including intake, reconciliations, and...

  • Quality Systems and Compliance Specialist

    6 days 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 Systems and Compliance Specialist

    6 days 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 Systems and Compliance Specialist

    1 day ago

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

    Job OverviewThis role involves supporting Quality Systems and Compliance by managing product complaint handling, acting as document control backup, and assisting with regulatory inspection preparation.Key ResponsibilitiesManage product complaint intake and coordination with partners for timely resolution and safety compliance.Develop training and assist in...

  • Manufacturing Quality Assurance Specialist

    4 weeks ago

    Cambridge, Massachusetts, United States The Accuro Group Full time

    Position Title: | Manufacturing Quality Assurance SpecialistLocation: RemoteJob Type: Contract (12 Months)Note: Parking expenses are not covered by the organization.Important: A background in manufacturing is essential.Position Overview:The Accuro Group is a leading biopharmaceutical organization dedicated to advancing science, technology, and talent to...

  • Quality Assurance Specialist II

    1 month ago

    Cambridge, United States Randstad Life Sciences US Full time

    Exciting Pharmaceutical Company has a contract QA Specialist Position!Competitive Pay: Up to $61.63/HR W2. NO 1099 OR C2C optionTitle: QA SpecialistPosition type: This is a 1 year contract position with potential for extensionWork Hours: Monday-Friday 2nd shift 3pm-11:30PMLocation: Cambridge, MAJob Summary:We are seeking a highly skilled and experienced...

  • Quality Assurance Specialist II

    1 month ago

    Cambridge, United States Randstad Life Sciences US Full time

    Exciting Pharmaceutical Company has a contract QA Specialist Position!Competitive Pay: Up to $61.63/HR W2. NO 1099 OR C2C optionTitle: QA SpecialistPosition type: This is a 1 year contract position with potential for extensionWork Hours: Monday-Friday 2nd shift 3pm-11:30PMLocation: Cambridge, MAJob Summary:We are seeking a highly skilled and experienced...

  • GCP Quality Assurance Specialist

    2 days ago

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

    Job Title: GCP Quality Assurance SpecialistLocation: Cambridge, MA (Hybrid)Job Overview: Stratacuity is seeking a GCP Quality Assurance Specialist to oversee compliance and quality processes for clinical trials, managing relationships with CROs, Investigator Sites, and stakeholders.Key Responsibilities:Develop and maintain GCP Quality Systems and SOPs to...

  • Quality Assurance Specialist

    1 week ago

    Cambridge, Maryland, United States Regal Rexnord Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Regal Rexnord. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by inspecting and testing them according to specifications and standards.Key ResponsibilitiesInspect and Test Products: Conduct thorough inspections and...

  • Quality Systems Director

    1 week ago

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

    About MEDIPOST America, Inc.MEDIPOST America, Inc. is a leading biotechnology company specializing in the development of novel umbilical cord-derived stem cell therapies for the treatment of degenerative diseases.Our flagship product, CARTISTEM, is a groundbreaking allogeneic stem cell therapy for moderate to severe knee osteoarthritis, approved in Korea...

  • Senior System Quality Assurance Specialist

    6 days ago

    Cambridge, Massachusetts, United States Draper Labs Full time

    Job DescriptionDraper Labs is seeking a highly skilled Senior System Quality Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring that our products meet the highest quality standards.Key ResponsibilitiesInvestigate and resolve quality issues in a timely and efficient manner.Review and analyze Statements of...

Quality Systems Specialist

4 months ago

Cambridge, United States Randstad Life Sciences US Full time

*6-month contract with the potential to extend*

100% on-site in Cambridge, MA

9AM-5PM Shift


Job Description

As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with company policies, QMS standards, and local regulations. You will report to the QMS Manager.


This position provides the opportunity to work directly with Manufacturing, Facilities, QA, and QC staff to manage QA Compliance activities for the Binney St. site in Cambridge, MA. The primary focus of this role will be to support the management of Quality Systems (deviation, CAPA, and change control). Other activities may arise.

Job Responsibilities

  • Manage overall health of Quality Systems by trending Key Performance Indicators (KPIs) to support continuous improvement and to identify, escalate, and resolve abnormalities or concerns.
  • Ensure quality operations and processes are in full compliance with company standards and policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and local regulatory requirements.
  • Compile and analyze metrics for documentation, deviation, CAPA, and change control. Develop and maintain dashboards and presentation graphics on a regular basis.
  • Coordinate and facilitate recurring governance meetings with task owners across departments to manage timelines.
  • Lead improvement projects to streamline and simplify processes in alignment with company standards and regulations.
  • Perform Quality System process confirmations to ensure processes and systems are appropriately managed. Ensure audit readiness for Quality Systems at the site.
  • Support Quality Systems risk identification and timely mitigation activities.

Education & Qualifications

  • Bachelor's degree or equivalent experience.
  • 3+ years of related experience.
  • High attention to detail
  • Strong analytical and organizational skills
  • Familiarity with Quality Systems (deviations, CAPAs, and change controls)
  • Proficiency in: Excel and Smartsheet data analysis
  • Making clear, concise, and consistent PowerPoint presentations
  • Confident facilitation skills to lead governance meetings and work with task owners to monitor timelines
  • Professional demeanor when presenting to senior leadership