Top 305 Senior document specialist Jobs in Boston Ma

Sr. Quality Specialist, GxP Document Control
Bicara Therapeutics —Boston, MA
- $105,000 - $128,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor's degree
- Training & development
GMP Operational Quality Senior Specialist (Stability)
Vertex Pharmaceuticals —Boston, MA
- $94,200 - $141,200 a year
- Full-time
- Hybrid work
- 3 years
- Bachelor's degree
- Organizational skills
- Loan repayment program
- Dental insurance
Senior Specialist, Regulatory Operations
Care Access —Boston, MA
- $90,000 - $100,000 a year
- Full-time
- Remote
- Microsoft Word
- Pass drug screening
- Bachelor's degree
- Health savings account
- Paid holidays
7d
Administrative Specialist
Northeastern University —Boston, MA
- $53,615.00 - $75,728.75 a year
- Multiple hires
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Data analysis skills
- Health insurance
- Dental insurance
Senior ADA Specialist Remote Tufts Medicine
Tufts Medicine —Burlington, MA
- $84,300.22 - $107,481.20 a year
- Full-time
- Remote
- Microsoft Excel
- Microsoft Outlook
- Bachelor of Science
7d
Archive Senior Specialist, Global Quality Systems and Compliance (Contract)
Vertex Pharmaceuticals —Boston, MA
- $46 - $49 an hour
- Temporary
- Microsoft Excel
- Mid-level
- 3 years
13d
Senior Specialist – CMC Data Steward – DSCS Digital
Merck —Boston, MA
- $117,000 - $184,200 a year
- Full-time
- Computer science
- Computer Science
- Mid-level
- Paid holidays
- Health insurance
9h
Senior QA Specialist
Editas Medicine —Cambridge, MA
- $110,000 - $120,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Senior level
- Health savings account
- Disability insurance
Quick Apply
4d
Administrative Specialist I
Dana-Farber Cancer Institute —Brighton, MA
- $50,070 - $60,730 a year
- Full-time
- Hybrid work
- Office
- High school diploma or GED
- Bachelor's degree
Senior Data Specialist
Contact Government Services, LLC —Boston, MA
- $80,000 - $100,000 a year
- Full-time
- Computer science
- Computer Science
- Data analysis skills
- Health insurance
- Dental insurance
Quick Apply
Nurse Care Manager
Hearth INC —Roxbury, MA
- From $95,000 a year
- Full-time
- Background check
- CPR Certification
- Nursing
- Wellness program
- Disability insurance
Quick Apply
Physical Therapist - (SIGN ON BONUS!) Watertown, MA
FOX Rehabilitation —Watertown, MA
- $70,000 - $110,000 a year
- Part-time
- CPR Certification
- BLS Certification
- Physical & Rehabilitation Medicine
- Health insurance
- Dental insurance
Mechanical Engineer - Senior
Aperture LLC —Burlington, MA
- $130,000 - $180,000 a year
- Full-time
- Hybrid work
- Customer service
- Bachelor of Science
- Office
- Paid holidays
- Health insurance
Quick Apply
Onsite Senior Technician
Custom Computer Specialists —Boston, MA
- $50,000 - $65,000 a year
- Full-time
- Microsoft Excel
- Mid-level
- Office
- Paid holidays
- Disability insurance
Quick Apply
AIRx, Sr. Director, Nonclinical Safety Lead
Takeda Pharmaceutical —Boston, MA
- $212,000 - $333,190 a year
- Call employer
- Hybrid work
- 11+ years
- Business development experience
- Doctor of Philosophy
- Paid holidays
- Disability insurance
Technical Sales Support Engineer
Socomec, Inc. —Watertown, MA
- $90,000 a year
- Full-time
- Spanish
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
7d
Arch Energy Senior Building Automation System Specialist
Consigli Construction —Boston, MA
- $116,000 - $127,000 a year
- Full-time
- 7 years
- Construction site
- Computer literacy
Quick Apply
Occupancy Specialist/Leasing Specialist
Beacon Communities LLC —Brockton, MA
- $27.70 - $33.30 an hour
- Full-time
- Microsoft Excel
- Sales
- Mid-level
- Health savings account
- Paid holidays
Quick Apply
Engineering Specialist (DevOps) Lead
Fresenius Kabi —North Andover, MA
- $170,000 - $180,000 a year
- Full-time
- Hybrid work
- Background check
- Azure
- DevOps
- Wellness program
- Paid holidays
Quick Apply
Regional Compliance Specialist (Quincy Regional Office/Northeast Region)
WinnCompanies —Quincy, MA
- $80,000 - $92,000 a year
- Weekends as needed
- Management
- 5 years
- English
- Health savings account
- AD&D insurance
Quick Apply

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senior document specialist jobs near boston ma

Sr. Quality Specialist, GxP Document Control

Bicara Therapeutics
Boston, MA

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Job Details

Full-time
$105,000 - $128,000 a year

Qualifications

Spreadsheets

Full Job Description

Position Overview

Bicara Therapeutics is seeking a Senior QA Specialist, GxP Document Control and Quality Systems to support the administration, organization, and continuous improvement of the Quality Management System (QMS). This role reports to the Sr. Director, GxP Quality Management Systems. This role serves as a key resource for document control, quality systems coordination, audit scheduling and tracking, and general QA operational support. Core to this work is ensuring quality documentation is accurate, organized, inspection-ready, and maintained in accordance with company procedures and applicable GxP requirements.

This role is based in Boston with a hybrid schedule (three days onsite per week).

Responsibilities

Lead day-to-day document control activities within the electronic QMS, including development, formatting, routing, review, approval, issuance, revision, archival, and retirement of controlled documents (SOPs, forms, templates, logs) in accordance with company procedures and applicable GxP requirements.
Organize, maintain, and archive GxP documentation that exists outside the formal QMS structure, ensuring it’s inspection-ready and easily retrievable.
Serve as a key operational support resource for the GxP QMS function, partnering closely with the GMP Operations & Supplier Management and Clinical GCP Quality teams to support quality systems activities across the organization.
Develop and maintain training curriculum and GxP tracking, support administration of Deviation/CAPA support, Change Control, Management Review processes and inspection readiness.
Support internal and external audit scheduling and logistics, track audit status, and assist with follow-up activities as needed to support Director, GxP Auditing.
Develop and maintain quality metrics, dashboards, trackers, and trending tools (including Smartsheet and Microsoft Excel) to support QA operational oversight, compliance monitoring, management review, and continuous improvement initiatives.
Collaborate cross-functionally with Quality and other departments (internally and externally) to support ongoing quality systems improvements and ensure compliance with applicable GxP requirements, including GCP and GMP activities.
Support additional Quality Systems initiatives and operational activities as assigned by the Senior Director, GxP Quality Management Systems.

Qualifications

Bachelor’s degree in a scientific discipline or equivalent combination of education and relevant industry experience.
Minimum 5+ years of experience in Quality Assurance, Quality Systems, or Document Control within the biotechnology, pharmaceutical, or other regulated industry.
Experience working within GxP-regulated environments, including support of GCP and/or GMP quality systems activities.
Working knowledge of document control processes and electronic Quality Management Systems (eQMS).
Experience supporting quality systems activities such as audits, CAPAs, training management, controlled documentation, inspection readiness, and quality metrics reporting.
Strong proficiency in Microsoft Excel and experience using Smartsheet or similar electronic tracking and reporting tools.
Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and timelines in a fast-paced environment.
Strong attention to detail with the ability to work both independently and collaboratively across functions.
Excellent written and verbal communication skills.
Experience in clinical-stage biotechnology or pharmaceutical environments preferred.

Company Overview

Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Compensation Range: $105K - $128K

Apply Now

Refine Your Search

senior document specialist jobs in boston ma

Sr. Quality Specialist, GxP Document Control

GMP Operational Quality Senior Specialist (Stability)

Senior Specialist, Regulatory Operations

Administrative Specialist

Senior ADA Specialist Remote Tufts Medicine

Archive Senior Specialist, Global Quality Systems and Compliance (Contract)

Senior Specialist – CMC Data Steward – DSCS Digital

Senior QA Specialist

Administrative Specialist I

Senior Data Specialist

Nurse Care Manager

Physical Therapist - (SIGN ON BONUS!) Watertown, MA

Mechanical Engineer - Senior

Onsite Senior Technician

AIRx, Sr. Director, Nonclinical Safety Lead

Technical Sales Support Engineer

Arch Energy Senior Building Automation System Specialist

Occupancy Specialist/Leasing Specialist

Engineering Specialist (DevOps) Lead

Regional Compliance Specialist (Quincy Regional Office/Northeast Region)

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