Senior QA Specialist, Document Control

1 day ago

Boston, United States Disability Solutions Full time

About the Job

The Senior QA Specialist, Document Control works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit. 

The Senior QA Specialist, Document Control leverages their experience to lead programs, mentor their peers, develop and implement regulation-adherent processes, lead assessments and process improvements to further improve quality functions, formalized procedures, operations and systems. The Senior Specialist is responsible in order of business priority for inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and recommendations to improve the quality of processes and products. 

Key Responsibilities

  • Act as the administrative leader for electronic Document Management System (eDMS) Veeva Vault. 
  • Coordinate all aspects of the full operation, implementation, and maintenance of the eDMS for controlled issue, retrieval, archiving of regulated documents to support site operations. 
  • Support and take ownership in the new product development document creation project, supporting new documents as needed in set-up, formatting, editing/processing, and collaborating with the team. 
  • Ensure quality and detail in creation/management of documents, and in the technical word-processing/editing of SOPs and other documents. 
  • Responsible for maintaining, updating, and versioning of all policies and procedures and forms. 
  • Perform document quality checks on all controlled documents in the eDMS. 
  • Coordinate the management of periodic review for required documents within the eDMS. 
  • Assist document owners in creating documents and workflows in eDMS. 
  • Create new user accounts in eDMS system (Veeva), and grant access to users for DocuSign access. 
  • Support implementation of corporate Records Schedule and Retention Program. 
  • Serve as primary contact for all archiving of validation documentation and scan all documents in need of upload to the server. 
  • Maintain and oversee Quality controlled records storage QA Document Control Room. 
  • Lead Biopharma and/or FDA and other regulatory agency inspections for the backroom support/document retrieval. 
  • Participate and prepare for Biopharma and/or other audits/inspections. Complete pre-audit requests for documentation and participate as a team member in the Audit Back Room. 
  • Co-share responsibilities in the Audit Front Room on an as needed basis. 
  • Work closely with the Quality Design Assurance department to continue the Design History File migration of documents to Veeva.
  • Issue Laboratory Notebooks and document IDs on an as needed basis. 
  • Manage the process for offsite storage of documents to Iron Mountain. 
  • Work with management in compiling required metrics and data for Quality Management Review to meet regulatory requirements.
  • Monitor and respond to requests made within the QDocs Hypercare Slack channel. 
  • Maintain the disaster recovery binders with latest documentation in the QA SharePoint. 
  • Provide support to the Training Manager with the training matrix, and any training related tasks in the Cornerstone system. Additional support to other QA activities as needed. 
  • Comply with the hybrid-role of 3 days per week minimum required onsite, 2 days remote. 
  • Maintain availability to work outside of regularly scheduled shift as needed to support the labs. 
  • Maintain attention to detail in a fast-paced workflow environment. 
  • Other duties as assigned. 

Qualifications

Basic Qualifications

  • Bachelor’s degree or related field with 5+ years experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment, OR
  • Associate’s degree in science or related field with 7+ years experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment, OR
  • High School Diploma or General Education Degree with 9+ years of strong experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment 

Preferred Qualifications

  • Experience working with electronic document management and quality management systems highly preferred. Experience with Veeva Vault is a plus
  • Previous Document Control or Record Management experience required
  • Exposure to regulatory compliance knowledge including GMP, ISO 13485, ISO 15189, CAP/CLIA, NYS, states, GCP, IVDR, and 21 CFR Part 11 Compliance
  • Demonstrated ability to lead teams and mentor staff
  • Ability to multitask within specified timelines
  • Ability to work well under pressure while maintaining a professional demeanor
  • Detailed oriented with excellent prioritization and organizational skills
  • Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with departments and colleagues
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion.

#LI-Hybrid

  • Senior QA Specialist, Document Control

    3 days ago

    Boston, United States Foundation Medicine Full time

    Job DescriptionAbout the Job The Senior QA Specialist, Document Control works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics,...

  • Documentation Specialist

    1 month ago

    boston, United States Insight Global Full time

    Position: Documentation SpecialistLocation: 316 Northern Ave, Boston, MA - HYBRID (3x onsite can choose which days)Pay: $40-60/hr (2 openings - Mid-Level & Senior Levels)Start Date: 1/2/2025Day-to-Day:The Senior Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision. The Senior Specialist...

  • Documentation Specialist

    1 month ago

    Boston, United States Insight Global Full time

    Position: Documentation SpecialistLocation: 316 Northern Ave, Boston, MA - HYBRID (3x onsite can choose which days)Pay: $40-60/hr (2 openings - Mid-Level & Senior Levels)Start Date: 1/2/2025Day-to-Day:The Senior Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision. The Senior Specialist...

  • Documentation Specialist

    4 weeks ago

    Boston, United States Insight Global Full time

    Position: Documentation SpecialistLocation: 316 Northern Ave, Boston, MA - HYBRID (3x onsite can choose which days)Pay: $40-60/hr (2 openings - Mid-Level & Senior Levels)Start Date: 1/2/2025Day-to-Day:The Senior Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision. The Senior Specialist...

  • Documentation Specialist

    4 weeks ago

    Boston, MA, United States Insight Global Full time

    Position: Documentation SpecialistLocation: 316 Northern Ave, Boston, MA - HYBRID (3x onsite can choose which days)Pay: $40-60/hr (2 openings - Mid-Level & Senior Levels)Start Date: 1/2/2025Day-to-Day:The Senior Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision. The Senior Specialist...

  • Senior QA Engineer

    6 days ago

    Boston, United States Escher Group Full time

    The Senior QA Engineer is responsible for executing different testing activities from preparation of test cases using user stories, use cases, or requirements to testing execution until the completion of deliverables to the customer. The Senior QA Engineer should be able to work independently for any size project and support other QA Engineers in their...

  • Senior QA Engineer

    1 week ago

    Boston, United States Escher Group Full time

    The Senior QA Engineer is responsible for executing different testing activities from preparation of test cases using user stories, use cases, or requirements to testing execution until the completion of deliverables to the customer. The Senior QA Engineer should be able to work independently for any size project and support other QA Engineers in their...

  • Senior QA Engineer

    4 weeks ago

    Boston, United States Escher Group Ltd. Full time

    The Senior QA Engineer is responsible for executing different testing activities from preparation of test cases using user stories, use cases, or requirements to testing execution until the completion of deliverables to the customer. The Senior QA Engineer should be able to work independently for any size project and support other QA Engineers in their...

  • Senior QA Engineer

    1 week ago

    South Boston, United States Escher Group Full time

    The Senior QA Engineer is responsible for executing different testing activities from preparation of test cases using user stories, use cases, or requirements to testing execution until the completion of deliverables to the customer. The Senior QA Engineer should be able to work independently for any size project and support other QA Engineers in their...

  • Documentation Specialist

    3 weeks ago

    Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req #2787 Monday, November 18, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for...

  • Documentation Specialist

    3 weeks ago

    Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req #2787 Monday, November 18, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for...

  • Documentation Specialist

    1 month ago

    Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req #2787 Tuesday, November 5, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for...

  • Documentation Specialist

    1 month ago

    Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req #2787 Tuesday, November 5, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for...

  • Documentation Specialist

    1 week ago

    Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req #2787 Monday, December 2, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for...

  • Documentation Specialist

    1 week ago

    Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req #2787 Monday, December 2, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for...

  • Documentation Specialist

    3 weeks ago

    South Boston, United States Bay Cove Human Services Full time

    Documentation Specialist - DS Individual Supports Boston, MA, USA Req 2787 Tuesday, November 12, 2024 Mission Statement: Bay Cove Human Services partners with people to overcome challenges and realize personal potential. Job Summary: The Documentation & Administrative Coordinator reports directly to the Senior Program Director for Supported Housing. He/she...

  • Senior IT QA Analyst, Enterprise Business Solutions

    3 months ago

    Boston, United States Berkshire Hathaway Specialty Insurance Full time

    Job Opportunity:   Berkshire Hathaway Specialty Insurance (BHSI) has an exciting opportunity for an experienced IT Quality Assurance Professional to join our Boston based Information Technology Team. BHSI provides commercial property, casualty, healthcare professional liability, surety, executive, and professional lines insurance to global customers....

  • Senior Specialist GMP Operational Quality

    3 months ago

    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...

  • Senior Quality Control Stability Specialist

    5 months ago

    Boston, United States CRISPR Therapeutics Full time

    Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and...

  • Senior Quality Control

    14 hours ago

    Boston, United States CRISPR Therapeutics Full time

    Company OverviewSince its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare...