Top 44 Document specialist Jobs in Boston Ma

Risk Assessment / Technical Document Spec.(GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148
TechData Service Company, LLC —Lexington, MA
- $60 - $100 an hour
- Temporary
- Hybrid work
- Microsoft Excel
- Engineering
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
2d
Source Document Specialist
Care Access —Boston, MA
- $30 - $35 an hour
- Remote
- Microsoft Word
- Microsoft Outlook
- Computer literacy
- Health savings account
- Paid holidays
4d
Document Specialist
Ipsen Innovation (SAS) —Cambridge, MA
- $91,500 - $134,200 a year
- Full-time
- Background check
- Microsoft Excel
- Doctoral degree
- Commuter assistance
- Disability insurance
Document Control Specialist (Hybrid Schedule - Construction)
RG Vanderweil.com —Boston, MA
- $35 - $40 an hour
- Hybrid work
- Office
- Bachelor's degree
- Organizational skills
- Wellness program
- Flexible schedule
Quick Apply
8d
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
8d
Quality Compliance & Document Control Coordinator -Manufacturing
Schulte Staffing Solutions —Peabody, MA
- $60,000 - $65,000 a year
- Full-time
- Background check
- Mid-level
- In-person
- Paid holidays
- Health insurance
Quick Apply
12d
Automotive Document Scanner / File Clerk
METROWEST AUTO GROUP —Framingham, MA
- From $17 an hour
- Part-time
- Background check
- 18 years or older
- Microsoft Outlook
- 401(k)
- 401(k) matching
Quick Apply
2d
Documentation Control Specialist
Advantage Technical —Beverly, MA
- $60,000 - $65,000 a year
- Full-time
- Mid-level
- Continuous improvement
- Communication skills
- Paid holidays
- Disability insurance
Quick Apply
12d
Clinical Documentation Improvement Specialist
Beth Israel Lahey Health —Charlestown, MA
- $102,000 - $158,392 a year
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
Clinical Documentation Specialist I-CDI
Beth Israel Lahey Health —Winchester, MA
- $85,000 - $132,000 a year
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
Document Specialist I
Computershare —Canton, MA
- $20 an hour
- Full-time
- Office
- Microsoft Office
- High school diploma or GED
- Paid parental leave
- Paid holidays
Documentation Clerk
Nova Biomedical —Waltham, MA
- $28 - $30 an hour
- Full-time
- Hybrid work
- Ability to sit for extended periods
- Organizational skills
- Ability to lift 25 pounds
- Paid holidays
- Health insurance
Quick Apply
Inpatient Clinical Documentation Integrity Risk Adjustment Specialist
Mass General Brigham Incorporated —Somerville, MA
- $79,560.00 - $115,720.80 a year
- Full-time
- Remote
- RN License
- Research
- 3 years
- Opportunities for advancement
Quick Apply
Senior Consultant - Clinical Documentation Specialist
Deloitte —Boston, MA
- $110,700 - $218,300 a year
- Full-time
- Microsoft Word
- Nursing
- RN License
Clinical Documentation Specialist II- RN- Remote
Beth Israel Lahey Health —Charlestown, MA
- $102,000 - $158,392 a year
- Full-time
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
Document Control Associate
Sebela Pharmaceuticals Inc. —Holbrook, MA
- $22 - $26 an hour
- Mid-level
- High school diploma or GED
- Organizational skills
Quick Apply
Document Administrator II
Bank of America —Waltham, MA
- $25.00 - $36.06 an hour
- Full-time
- Customer service
- Writing skills
- Research
10d
Document Control Specialist
Westinghouse Electric Company —Norwell, MA
- $30 - $35 an hour
- Microsoft Access
- Mid-level
- Office
- Health insurance
- 401(k)
Documentation Control Coordinator (Contract)
TransMedics, Inc. —Andover, MA
- Full-time
- Mid-level
- Office
- 3 years
- Employee stock purchase plan
- Disability insurance
Quick Apply
Manager, Document Control and Training
Monte Rosa Therapeutics, Inc —Boston, MA
- $90,000 - $120,000 a year
- Full-time
- 8 years
- Bachelor's degree
- Senior level

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Risk Assessment / Technical Document Spec.(GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148

TechData Service Company, LLC -
Lexington, MA

Quick Apply

Job Details

Temporary | Full-time
$60 - $100 an hour
2 days ago

Benefits

Health insurance
Dental insurance

Qualifications

Data integrity assurance
Sourcing
Teamwork
Microsoft Excel
Content creation for technical audiences
GxP
Compliance audits & assessments
Visio
Good documentation practices (GDP)
Data quality management
Bachelor's degree
Pharmaceutical company experience
Organizational skills
Contracts
IT
Productivity software
Technical writing experience within technology
Cross-functional collaboration
Standard operating procedures (SOPs)
Bachelor of Arts
Project stakeholder communication
Cross-functional communication
Standard operating procedures drafting
SDLC

Full Job Description

Risk Assessment / Technical Document Specialist (GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148

BB10148

Lexington, MA

12+ Months

This role will serve as a SME across both IT systems and data integrity, ensuring solutions are compliant, inspection-ready, and operationally efficient.

12 Month contract with potential to extend

Onsite Expectations:
For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and starting working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed.

Primary Duties

This contractor role is responsible for modernizing technical system documentation across Quality Control Lab Systems and performing structured data integrity risk assessments to enable risk-based optimization of procedural controls.

The consultant will partner cross-functionally with Quality, IT, and Business Process Owners to:

· Simplify, standardize, and modernize system documentation (e.g., FRS, SDCS, Admin SOPs, O&M procedures) in alignment with global templates

· Apply Client global Quality Risk Management (QRM) / ICH Q9 principles to evaluate data integrity controls such as audit trail review, backup/restore verification, and user access management

· Provide recommendations to optimize the frequency and design of controls

Responsibilities

1. Technical Documentation Modernization (~50%)

· Assess current-state system documentation across QC GxP systems

· Redesign and standardize documentation structure aligned to SDLC and validation expectations (e.g., FRS, SDCS, SOPs) and global templates

· Ensure documentation aligns with:

o 21 CFR Part 11

o Data integrity expectations

o Internal validation, SDLC and QMS standards

· Partner with system owners and SMEs to validate accuracy and usability of modernized documents

· Identify opportunities to digitize, automate, or rationalize documentation and lifecycle processes in collaboration with QC IT team

2. Data Integrity Risk Assessments & Control Strategy Optimization (~50%)

· Facilitate and execute structured risk assessments using QRM principles (e.g., ICH Q9 methodologies)

· Evaluate data integrity risks across system processes, including:

o Administrative Audit trail Reviews

o User access and privileges

o Data backup and restore

· Assess the effectiveness, redundancy, and burden of existing controls

· Develop risk-based recommendations for:

o Adjusting frequency of audit trail reviews

o Optimizing backup/restore verification approaches

o Rationalizing user account management processes

· Document risk assessments with clear:

o Risk statements

o Impact/severity scoring

o Detectability and mitigation strategies

· Support development of remediation or optimization plans based on findings

· Align outputs with site DI program expectations and governance forums

Education and Experience Requirements

Education

· Bachelor’s degree in Science, Engineering, Information Technology, or related field (required)

Experience

· Experience in GxP-regulated pharmaceutical or biotech environments (required)

· Demonstrated experience with:

o Technical system documentation (FRS, SDCS, SOPs)

o Computerized Systems Validation (CSV) and system lifecycle management

· Experience leading or facilitating Quality Risk Management activities (preferred)

· Strong understanding of data integrity principles and regulatory expectations (required)

· Experience performing data integrity assessments or remediation activities (preferred)

· Experience working cross-functionally in a matrixed organization

Key Skills, Abilities, and Competencies

· Strong knowledge of:

o Data integrity regulations and expectations (ALCOA+, Part 11)

o Risk-based decision making and QRM methodologies

· Ability to translate complex technical systems into simplified, user-friendly documentation

· Expertise in evaluating system controls (audit trails, access, backups, interfaces)

· Strong facilitation skills for risk assessments and cross-functional workshops

· Analytical thinking with ability to challenge legacy practices and drive simplification

· Effective communication skills across technical and non-technical stakeholders

· Ability to operate independently with minimal oversight in a fast-paced environment

Complexity and Problem Solving

· Applies risk-based judgment to evaluate compliance vs. operational efficiency trade-offs

· Makes recommendations that may significantly change control strategies or reduce operational burden

· Balances regulatory expectations with pragmatic, scalable solutions

· Works across multiple systems, functions, and stakeholders simultaneously

Other Job Requirements

· Role role requires on-site presence for workshops, risk assessments, and stakeholder engagement

· Strong proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Visio)

TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Job Types: Full-time, Temporary

Pay: $60.00 - $100.00 per hour

Benefits:

Dental insurance
Health insurance

Application Question(s):

What City/State are you currently located in?
What hourly rate are you seeking?

Education:

Bachelor's (Required)

Experience:

Control Strategy Optimization: 1 year (Preferred)
Risk-Based Decision Making: 1 year (Preferred)
QRM Methodologies: 1 year (Preferred)
ALCOA+: 1 year (Preferred)
GxP Regulated Pharmaceutical /Bio-Tech Industry: 2 years (Required)
Risk Assessment: 1 year (Preferred)
Technical System Documentation: 3 years (Required)
IT Data Integrity: 3 years (Required)
IT Systems: 3 years (Required)
QC GxP systems: 1 year (Required)
Validations: 1 year (Required)
SDLC: 1 year (Required)

Work Location: Hybrid remote in Lexington, MA 02420

Quick Apply

Refine Your Search

document specialist jobs in boston ma

Risk Assessment / Technical Document Spec.(GxP/Bio-Tech Exp Required) – Hybrid/W2 only – BB10148

Source Document Specialist

Document Specialist

Document Control Specialist (Hybrid Schedule - Construction)

Sr. Quality Specialist, GxP Document Control

Quality Compliance & Document Control Coordinator -Manufacturing

Automotive Document Scanner / File Clerk

Documentation Control Specialist

Clinical Documentation Improvement Specialist

Clinical Documentation Specialist I-CDI

Document Specialist I

Documentation Clerk

Inpatient Clinical Documentation Integrity Risk Adjustment Specialist

Senior Consultant - Clinical Documentation Specialist

Clinical Documentation Specialist II- RN- Remote

Document Control Associate

Document Administrator II

Document Control Specialist

Documentation Control Coordinator (Contract)

Manager, Document Control and Training

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