Top 44 Document specialist Jobs in Cambridge, Ma

Document Control Associate
American Surgical Company —Beverly, MA
- $65,000 - $85,000 a year
- Full-time
- Computer literacy
- Mid-level
- Office
- Health savings account
- Disability insurance
Quick Apply
4d
Document Control Specialist
Connexion Systems and Engineering, Inc. —Beverly, MA
- $70,000 - $75,000 a year
- Full-time
- Mid-level
- 3 years
- Continuous improvement
- Health insurance
- Dental insurance
Quick Apply
3h
Documentation Control Coordinator (Contract)
TransMedics, Inc. —Andover, MA
- Full-time
- Mid-level
- Office
- 3 years
- Employee stock purchase plan
- Disability insurance
Quick Apply
Document Imaging Representative
MIT —Cambridge, MA
- Full-time
- HIPAA
- Mid-level
- High school diploma or GED
2d
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
Clinical Documentation Specialist I-CDI
Beth Israel Lahey Health —Winchester, MA
- $85,000 - $132,000 a year
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
Source Document Specialist
Care Access —Boston, MA
- $30 - $35 an hour
- Remote
- Microsoft Word
- Nursing
- Microsoft Outlook
- Health savings account
- Paid holidays
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 II- RN- Remote
Beth Israel Lahey Health —Charlestown, MA
- $102,000 - $158,392 a year
- Full-time
- Remote
- Nursing
- Microsoft Excel
- Microsoft Outlook
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
Sr Quality Assurance Documentation Specialist
Candel Therapeutics —Needham, MA
- $88,000 - $100,000 a year
- Full-time
- Hybrid work
- Microsoft Excel
- 6 years
- Microsoft Outlook
11d
Senior Scientific Document Specialist
MEADOWHAWK BIOLABS INC —Marlborough, MA
- $68,500 - $88,000 a year
- Microsoft Excel
- Laboratory experience
- Master's degree
10d
Document Administrator II
Bank of America —Waltham, MA
- $25.00 - $36.06 an hour
- Full-time
- Customer service
- Writing skills
- Research
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
Document Control Associate
Sebela Pharmaceuticals Inc. —Holbrook, MA
- $22 - $26 an hour
- Mid-level
- High school diploma or GED
- Organizational skills
Quick Apply
Risk Assessment /Technical Document Specialist
USDM Life Sciences —Lexington, MA
- Contract
- Hybrid work
- Microsoft Excel
- Engineering
- Office
Document Controls Manager
WSP —Boston, MA
- $140,000 - $155,000 a year
- 7 years
- Microsoft Excel
- Supervising experience
- Paid parental leave
- Disability insurance
7d
Document Services Specialist
Ricoh —Boston, MA
- Overtime
- Hospitality
- Computer literacy
- Mid-level
Senior Consultant - Clinical Documentation Specialist
Deloitte —Boston, MA
- $110,700 - $218,300 a year
- Full-time
- Microsoft Word
- Nursing
- RN License
Document Control and Regulatory Compliance Coordinator
Harmonic Drive L.L.C. —Beverly, MA
- $60,000 - $65,000 a year
- Full-time
- English
- Mid-level
- Office

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Document Control Associate

American Surgical Company
Beverly, MA

Quick Apply

Job Details

Full-time
$65,000 - $85,000 a year
4 days ago

Benefits

Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Paid time off
Vision insurance
Life insurance

Qualifications

Records disposition policies
Foreign language proficiency
Content creation for technical audiences
Regulatory documents
Quality records maintenance
Computer literacy
Data Retention (Data management)
Bachelor's degree in business
Document control experience within manufacturing industry
Technical writing experience within manufacturing
Scanning
Training material drafting
Mid-level
Literature reviews
Trade compliance
Manufacturing facility experience
Export documentation management
Policy & process development
Bachelor's degree in engineering
Data classification
Task prioritization
Staff training
Compliance documentation
Quality compliance management
Desktop applications
Interdisciplinary policy and procedure development experience
Biomedical regulatory compliance
Associate's degree in engineering
Document imaging
Literature search services

Full Job Description

Summary

The Document Control Associate is responsible for administering and maintaining ASC's document control system to ensure controlled documents and records are created, reviewed, approved, distributed, revised, archived, and retained in accordance with the Company's Quality Management System and applicable regulatory requirements.

Duties

Establishing and/or administering a documentation filing system for all policies, procedures, specifications, and/or forms.
This may include creating, reviewing, collecting, updating, storing, retrieving, securing, controlling revisions and destruction of old records. This is typically done both for physical and electronic documents to ensure that official records are kept secure, up-to-date, and readily retrievable.
Coordinating the creation, review, revision, approval, and release of Standard Operating Procedures (SOPs), work instructions, specifications, forms, and validation protocols.
Maintain document revision history and ensure only current approved versions of documents are available for use throughout the organization.
Developing and utilizing classification systems to enable storage and quick retrieval of information.
Revising documents as needed and coordinating review and approval of SOPs, specifications, and forms.
Administering timely and appropriate distribution of documents (Assure updated documents are available and used.)
Maintain controlled documents within the company's electronic document management system (eDMS/eQMS).
Ensure document revisions, approvals, and obsolete document archival are completed in accordance with company procedures.
Support document change requests and Change Orders through the document approval process.
Track document status to ensure timely review and approval.
Perform periodic reviews of controlled documents to ensure continued accuracy and compliance.
Maintain document retention and archival records in accordance with company policies
Assisting in the training on policies, procedures, and forms for their use.
Participating in internal and external audits as required.
Establishing and maintaining best practices in handling of documents.
Keeping managers informed of situations that may affect documentation.
Identify document-related training needs and support company-wide compliance.
Prepare ad-hoc reports on projects as needed.
Technical Writing: Authoring regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.
Review and prepare labeling, training, promotional, and advertising material.
Assures consistent and standard process exists to perform proactive surveillance (e.g., regulatory database searches, literature reviews).
Assist with product and facility registrations globally, including requesting certificates.
Creating Global Trade Identification Numbers (GTIN), updating, and maintaining labeling databases such as Access GUDID and Eudamed.

Skills

Data driven
Team Player
Forward thinker
Positive mental attitude
Ability to accurately document information.
Ability to utilize imaging devices to scan and use computer software to transfer data from physical to electronic records.
Accuracy and attention to detail, including strong written and verbal communication skills.
Computer skills, including the ability to learn and use one or more versions of specialized software such as MS Office.
Ability to develop, implement and enforce policies and procedures.
Ability to manage multiple priorities.
Ability to perform detail-oriented work, coordinate multiple projects, perform presentations, and adapt to a flexible environment with changing daily workload and priorities as directed.
Organizational skills to track open items, persistence in follow-up and solid time management skills.

Education and Experience:

Associate's or Bachelor's degree in Business, Life Sciences, Engineering, Quality Assurance, or a related field preferred.
2–4 years of document control experience in a manufacturing or regulated operations environment, preferably within the medical device industry.
Experience using electronic Document Management Systems (eDMS/eQMS) preferred.
Working knowledge of ISO 13485 document control requirements preferred.
ISO 13485 Internal Auditor certification preferred.

Language Skills:

Must be fluent in English, with the ability to read, write, and communicate technical information clearly and effectively in both verbal and written formats.
Proficiency in Spanish is a plus and may be beneficial for effective communication in a diverse manufacturing environment.

Pay: $65,000.00 - $85,000.00 per year

Benefits:

401(k)
Dental insurance
Disability insurance
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

document specialist jobs in cambridge, ma

Document Control Associate

Document Control Specialist

Documentation Control Coordinator (Contract)

Document Imaging Representative

Documentation Clerk

Clinical Documentation Specialist I-CDI

Source Document Specialist

Clinical Documentation Improvement Specialist

Clinical Documentation Specialist II- RN- Remote

Sr. Quality Specialist, GxP Document Control

Sr Quality Assurance Documentation Specialist

Senior Scientific Document Specialist

Document Administrator II

Manager, Document Control and Training

Document Control Associate

Risk Assessment /Technical Document Specialist

Document Controls Manager

Document Services Specialist

Senior Consultant - Clinical Documentation Specialist

Document Control and Regulatory Compliance Coordinator

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