24 document control specialist jobs at 23 companies in Needham, MA
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Document Control, Senior Specialist
Bedford, Massachusetts, United States
$111k-$185k/yrHybridFull Time
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
Document Control Specialist (Norwell, MA, US, 02061)
Norwell or Edmonton or Superior or Duluth
$30-$35/yrHybridFull Time
WECTEC Staffing Services: Provides technical staffing and contingent labor for energy industries.
2+ YOEUniversity degree or technical diploma; 2+ years in document/records management; knowledge of drawing management systems; EDMSLink, BIM-JIRA, MS Access, Excel.
Specialist/Sr. Specialist, Quality – Document Control and Training
Lexington, Massachusetts, United States
$82k-$100k/yrOnsiteFull Time
Kiniksa PharmaceuticalsNASDAQ: KNSA: Developing and commercializing therapies for cardiovascular and inflammatory diseases.
3+ YOE3+ years regulated life science experience, bachelor's degree required, direct document control/quality systems/training experience, Veeva Vaults preferred, knowledge of US/EU cGMP preferred, Microsoft Office and eDMS/LMS proficiency.
Veeva Vaults, eDMS, LMS, Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, Microsoft SharePoint
3+ YOEBachelor's degree or equivalent; 3+ years document control experience in transportation or construction; Microsoft Office experience; familiarity with EDMS, SharePoint, Procore, InEight, eBuilder, Bluebeam; strong organization and communication skills.
Microsoft Office, Electronic Document Management System (EDMS), Microsoft SharePoint, Procore, InEight, eBuilder, Bluebeam, Microsoft 365
5+ YOEBachelor's in a scientific discipline (or equivalent), 5+ years QA/document control experience in regulated biotech/pharma, GxP/eQMS knowledge, audit/CAPA/training support, Smartsheet and Microsoft Excel proficiency.
electronic Quality Management Systems (eQMS), Smartsheet, Microsoft Excel
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)
CoorsTek: Manufacturer of engineered technical ceramics for global industrial markets.
2+ YOEInspect materials, in-process, and finished goods with precision measuring tools; verify specifications; document results and coordinate with production.
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
10+ YOEHigh school diploma and ~10 years industry experience with at least 6 years document control in biotech/pharmaceutical/medical device; eQMS/Master Control experience; advanced cGMP and FDA 21 CFR knowledge; CSV and change control experience; strong written/verbal communication.
Microsoft Office, electronic Quality Management System (eQMS), Master Control
Nova Biomedical: Develops and manufactures blood testing analyzers and diagnostic equipment.
3+ YOEThree to five years QA/QMS experience in regulated industries, Bachelor's preferred, experience with audits, document control, change control, CAPA, and ability to access manufacturing areas and lift 25 lbs.
Formlabs: Develops and manufactures professional-grade 3D printers and materials.
4+ YOE4+ years accounting experience with 2+ years SEC internal control reporting, COSO/internal control knowledge, SOX testing, audit documentation, NetSuite and Excel proficiency, strong communication and analytical skills.
Workiva, AuditBoard, NetSuite, Microsoft Excel, Google Suite
Schneider ElectricEuronext Paris: SU: Provider of energy management and industrial automation solutions.
2+ YOEHigh school or technical school education; 2+ years installing/servicing HVAC/access control and low-voltage controllers; ability to configure/calibrate field devices; follow safety protocols and document service activities.
ABCorp: Produces secure payment cards and provides additive manufacturing solutions.
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
4+ YOEBachelor's degree and 4+ years regulatory experience (or 2+ with advanced degree). Experience with Class II/III medical devices, global regulatory submissions, design controls, and regulatory documentation; RAC preferred.
Sun PharmaNSE: SUNPHARMA: Develops and manufactures generic and specialty pharmaceutical products worldwide.
3+ YOEKnowledge of GMP and quality systems, 3+ years supporting manufacturing or quality, CAPA/change control/deviation experience, training compliance tracking, documentation and QMS familiarity.
Active Secret clearance required, high school diploma minimum, ability to exercise discretion, prioritize and multi-task, proficiency with Microsoft 365, ability to lift 40 lbs; experience with document control and security processes preferred.
Experience in international logistics and export operations, knowledge of U.S. export control (AES, ENC) and trade documentation, strong analytical skills, ERP/Oracle/BI proficiency, and ability to coordinate with 3PLs and cross-functional teams. ITAR work requires U.S. Person or export license eligibility.