4+ YOEBachelor's degree or 4 years' direct experience; strong Microsoft Office skills; US person eligible for DoD security clearance; attention to documentation control and effective oral/written communication.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel
LantheusNASDAQ: LNTH: Develops and commercializes radiopharmaceutical and diagnostic imaging products.
8+ YOEBS/BA and 8+ years in quality (min 5 years in document control) in pharma/medical device/biologics, experience with eDMS/eQMS (TrackWise Digital, Veeva, MasterControl), GxP documentation, technical writing, and MS Office proficiency.
TrackWise Digital, Veeva, MasterControl, eDMS, eQMS, Microsoft Office
Cirtec Medical: Outsourced design and manufacturing for complex medical devices.
2+ YOEHigh school diploma or GED, 2 years of medical device document control experience, PLM and ERP experience, Microsoft Word and Excel proficiency, fluent English, and knowledge of FDA QSR and ISO 13485.
Master Control, Syteline, PLM, ERP, Microsoft Word, Microsoft Excel, CAPA, NCMR, QMS
The Middlesex Corporation: Constructs heavy civil infrastructure including highways, bridges, and rail.
2+ YOEBachelor's in engineering or construction management; 2+ years in construction quality control management; strong QA/QC, planning, and documentation skills; PM software experience.
Project management software, Construction QA/QC tools
TransMedicsNASDAQ: TMDX: Preserving and transporting donor organs for medical transplantation.
3+ YOE3-5 years in documentation control; HS diploma; familiar with eQMS; knowledge of FDA 21 CFR Part 820/Part 11, ISO 13485, EU MDR; strong attention to detail and communication; MS Office proficiency.
3+ YOEHigh school diploma, 3+ years related experience, familiarity with Microsoft Excel and Word, experience in document control or regulated/EMS manufacturing preferred; strong PC, organizational, and communication skills.
Microsoft Excel, Microsoft Word, Manufacturing Execution System (MES)
Eversource EnergyNYSE: ES: Delivers electricity, natural gas, and water to New England customers.
0+ YOEDocument control for engineering projects; 0-3 years experience; HS diploma or Associate; MS Office and Adept/SharePoint familiarity; willing to travel CT/MA/NH.
Microsoft Office, Adept, SharePoint, Teams, MS Access
Boston or United States or San Francisco or Seattle
$130k-$140k/yrRemoteFull Time
Jade BiosciencesNASDAQ: JBIO: Developing best-in-class therapies for autoimmune diseases.
5+ YOEBachelor's degree and 5-8+ years pharma/biotech R&D experience with 3-5+ years in document control; Veeva Basics, SharePoint and Microsoft Office proficiency; strong technical writing and records management skills.
Veeva Basics, Microsoft SharePoint, Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Document Control and Regulatory Compliance Coordinator
Beverly, Massachusetts, United States
$60k-$65k/yrOnsiteFull Time
Harmonic DriveTokyo Stock Exchange: 6324: Manufactures high-precision gears and motion control actuators.
Managing QMS document control and regulatory compliance (AS9100/ISO9001); administering QMS/document workflows, supporting audits and regulatory submissions; Microsoft Office proficiency; bachelor’s degree or equivalent.
Navis Food Partners: Independent foodservice distribution platform serving the Northeast United States.
2+ YOEInspect raw, in-process, and finished products for food safety and quality; perform facility and temperature inspections; document and report findings; participate in audits and corrective actions.
Lexington Medical: Designs and manufactures minimally invasive surgical stapling devices.
Inspect medical device components and finished products using precision tools, document nonconformances, maintain traceability, read blueprints, work in cleanroom/manufacturing environments, and use basic Excel for reporting.
calipers, micrometers, comparators, Microsoft Excel
Borg Design: Borg Design provides precision CNC machining and contract manufacturing services.
Prior inspection experience in a manufacturing/job shop environment; ability to use calipers, micrometers, height gauges, CMMs; read technical drawings and GD&T; detail-oriented and able to document inspection results. Must be US citizen or permanent resident, 18+, and English proficient.
Burlington StoresNYSE: BURL: Off-price retailer of apparel, footwear, and home goods.
Enforce shortage reduction and asset protection, engage customers and associates, document incidents, support audits and inventory, work flexible schedule including nights/weekends/holidays.
RepligenNASDAQ: RGEN: Develops and manufactures bioprocessing technologies for pharmaceutical drug production.
2+ YOEInspect incoming materials and manufactured parts, perform precision measurements, interpret drawings/specs, document results, and communicate non-conformances; 2+ years QA experience in regulated environments.
Microsoft Outlook, Microsoft Excel, Microsoft Word, Micro-Hite, calipers, comparators, Geometric Dimensioning and Tolerancing (GD&T), Safety Data Sheets (SDS)
LonzaSIX Swiss Exchange: LONN: Manufactures medicines and provides development services for healthcare companies.
Associate's degree in microbiology/biochemistry or related field, experience in GMP/regulated labs preferred, aseptic technique and cleanroom experience, strong data interpretation and documentation skills.
Sarepta TherapeuticsNASDAQ: SRPT: Develops precision genetic medicines for rare diseases.
2+ YOEHands-on experience with cell-based potency assays, cell culture, SDS-PAGE and western blot methods, GMP/BSL-2 lab practices, data documentation, and quality event management.
SDS-PAGE, Western blot, Automated Western blot, capillary based western blotting system
Mitsubishi Electric Research LaboratoriesTokyo Stock Exchange: 6503: Conducts fundamental research in AI, robotics, and signal processing.
MS or PhD student with strong C/C++ skills and hands-on microcontroller firmware experience, including embedded peripherals, protocols, testing, documentation, and maintainable software practices.
Quality Operations Program Manager - Document Control
Boston, Massachusetts, United States
$100k-$150k/yrRemoteFull Time
Veeva SystemsNYSE: VEEV: Cloud-based software solutions for the global life sciences industry.
5+ YOEBS/BA or equivalent, 5+ years in regulated quality role in life sciences, experience with QMS/eDMS/eQMS, strong knowledge of GxP and 21CFR11, process mapping and communication skills.
Veeva QualityDocs, Veeva QMS, Veeva Training, Veeva Quality Cloud, electronic Document Management System (eDMS), electronic Quality Management Systems (eQMS), SDLC