Top 34 Document specialist Jobs in Warren, Nj

Sr. Coordinator, Controlled Documentation & Training Compliance (2026-8004)
CareTria —New Jersey
- $50,000 - $60,000 a year
- Full-time
- Spanish
- Microsoft Excel
- Microsoft Outlook
6d
GMP Document Management
Pace Analytical Life Sciences —Lebanon, NJ
- $22 an hour
- Full-time
- Microsoft Outlook
- Mid-level
- Databases
- Wellness program
- Health savings account
Document Specialist
FBT Gibbons LLP —Newark, NJ
- $40 - $50 an hour
- Overtime
- Hybrid work
- Microsoft Word
- Mid-level
- 3 years
- Profit sharing
- Paid parental leave
7d
Document Control Specialist
Unipack Inc. —South Plainfield, NJ
- $45,000 - $60,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
4d
Senior Quality Specialist (Document Control and Record Management)
Insmed Incorporated —Bridgewater, NJ
- $100,000 - $126,500 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Office
- 3 years
- Employee stock purchase plan
- Disability insurance
6h
Medical Records Technician (Document Imaging)
University Hospital, Newark NJ —Newark, NJ
- $28.32 - $29.68 an hour
- Weekends as needed
- Microsoft Outlook
- Computer literacy
- English
- Health savings account
- Disability insurance
Quick Apply
7d
Specialist, Documentation
USPL NUTRITIONALS LLC —North Brunswick, NJ
- $65,000 - $75,000 a year
- Full-time
- Writing skills
- English
- Mid-level
- AD&D insurance
- Paid holidays
Quick Apply
Document Specialist
Marotta Controls, Inc. —Montville, NJ
- $33 - $36 an hour
- Computer literacy
- Office
- High school diploma or GED
- Paid holidays
- Disability insurance
Quick Apply
Quality Assurance Specialist - Document Control
electroCore Inc —Rockaway, NJ
- Full-time
- Microsoft Word
- Mid-level
- 2 years
9d
Regulatory Documentation Specialist II
ImmunityBio —Summit, NJ
- $45.66 - $50.23 an hour
- Full-time
- Mid-level
- Office
- High school diploma or GED
- AD&D insurance
- Disability insurance
Specialist, Quality Document Control
Rocket Pharmaceuticals —Cranbury, NJ
- $56,000 - $74,000 a year
- Full-time
- Microsoft Excel
- Mid-level
- 3 years
- Paid holidays
- Health insurance
Medicaid Authorization & Documentation Specialist
Volunteers of America - Greater New York, Inc. —Rahway, NJ
- $60,000 a year
- Full-time
- Mid-level
- Driver's License
- Bachelor's degree
- Paid holidays
- Health insurance
Quick Apply
Senior Consultant - Clinical Documentation Specialist
Deloitte —Morristown, NJ
- $110,700 - $218,300 a year
- Full-time
- Microsoft Word
- Nursing
- RN License
Specialist, Documentation
US Pharma Lab —North Brunswick, NJ
- Full-time
- Writing skills
- English
- Mid-level
- AD&D insurance
- Paid holidays
Clinical Documentation Specialist HIM
CareWell Health —East Orange, NJ
- $110,000 - $120,000 a year
- Per diem
- Medicine
- RN License
- Computer literacy
- Paid holidays
- Disability insurance
Quick Apply
9h
Documentation Review Nurse
Hunterdon Health —Flemington, NJ
- $93,077.77 - $116,347.21 a year
- Full-time
- Nursing
- RN License
- Bachelor of Science
- Health insurance
- Dental insurance
Quick Apply
Documentation and Training Specialist
Princeton Plasma Physics Laboratory —Princeton, NJ
- $93,400 - $149,200 a year
- Full-time
- Mentoring
- Senior level
- Associate's degree
- On-the-job training
Document Control Assistant - 2nd Shift
Amneal Pharmaceuticals —Piscataway, NJ
- $20 - $25 an hour
- Full-time
- Microsoft Word
- High school diploma or GED
- 1 year
- Health insurance
- 401(k) matching
Document Specialist
Sims Limited —Jersey City, NJ
- Mid-level
- Organizational skills
Quick Apply
4d
Video Documentation Specialist (Part Time)
Z5 Inventory —Newark, NJ
- $200 a day
- Part-time
- Hospital
- Ability to walk for extended periods
- Ability to lift 50 pounds
Quick Apply

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Sr. Coordinator, Controlled Documentation & Training Compliance (2026-8004)

CareTria
New Jersey

Apply Now

Job Details

Full-time
$50,000 - $60,000 a year
6 days ago

Qualifications

Computer operation
Microsoft Excel
Microsoft Outlook
Document control experience within pharmaceutical industry
Pharmaceutical regulatory compliance
Basic math
English
FDA 21 CFR Part 11
GMP
Training material drafting
Desktop applications
Technical writing
Standard operating procedures (SOPs)
Quality data entry
Standard operating procedures drafting

Full Job Description

The Senior Coordinator, Controlled Documentation & Training Compliance is an experienced, independently operating contributor responsible for executing and supporting the day-to-day operations of the controlled documentation and training compliance programs within a GxP-regulated 3PL/pharmaceutical distribution environment. Reporting to the Manager, this role carries greater technical depth, broader task ownership, and a functional oversight responsibility for the coordinator level. The Sr. Coordinator processes and manages controlled documents and training records with a high degree of accuracy and GDP compliance, assists with eDMS and learning management system operations, contributes to audit readiness activities, and provides day-to-day guidance to the coordinator. This role serves as a reliable operational resource for the team and is expected to work with minimal supervision on routine tasks while escalating complex issues appropriately.

**Must reside within a commutable distance from our Lakewood, NJ location.

KEY RESPONSIBILITIES:

Process, format, route for approval, file, and distribute controlled documents including SOPs, work instructions, forms, and policies — in accordance with established document control procedures and cGMP/GDP requirements.
Maintain and update document records in the eDMS with accuracy and completeness, ensuring proper version control, metadata entry, and lifecycle status tracking.
Track document expiration dates and review cycle timelines; proactively coordinate with process owners and the Manager to initiate timely renewals and revisions
Maintain comprehensive physical and electronic filing systems for controlled documents and quality records in compliance with retention schedules and regulatory requirements.
Verify that obsolete document versions are removed from active use and properly archived in accordance with document control procedures.
Perform GDP-compliant record reviews to verify completeness and accuracy of quality records, flag discrepancies to the Manager for resolution.
Prepare and organize document control packages for internal audits, client audits, regulatory inspections, and document change control activities.
Ensure confidentiality and controlled access of sensitive documentation in alignment with organizational policies and legal requirements.
Assist with the development and maintenance of document control work instructions and SOPs as directed.
Monitor training completion rates and identify at-risk or past-due training items; escalate proactively to the Manager prior to expiration.
Assist in developing and updating training materials including slide decks, assessments, and Read-and-Understand documents for GxP and SOP-based training programs.
Support new hire orientation by coordinating initial training assignments and verifying completion of required pre-task GxP, GDP, PDMA, and DSCSA training.
Compile and organize training completion data and generate routine compliance reports for review by the Manager.
Maintain all training records in an organized, accurate, and audit-ready state always.
Provide guidance and troubleshooting assistance to the Coordinator on LMS/eDMS tasks and training record questions.
Support audit and inspection preparation by retrieving training transcripts, qualification records, and document control packages; verify completeness and accuracy prior to submission.
Assist the Sr. Specialist and/or Manager during internal audits, client audits, and regulatory inspections by serving as a knowledgeable resource on document and training records.
Assist with tracking and follow-up on action items related to documentation or training deficiencies identified through audits, deviations, or CAPAs.

The above duties are meant to be representative of the position and not all-inclusive.

MINIMUM JOB REQUIREMENTS:

Education: Associate’s or bachelor’s degree in Life Sciences, Healthcare Administration, Business, or a related field; or equivalent combination of education and directly relevant experience.
Experience: 2–4 years of experience in document control, training coordination, quality administration, or a related role within an FDA-regulated environment (pharmaceutical, biotech, medical device, or 3PL/WD preferred).
Regulatory Knowledge: Working knowledge of cGMP, Good Documentation Practices (GDP), and foundational understanding of PDMA, DSCSA, and 21 CFR Part 11 documentation requirements.
Systems Experience: Demonstrated experience working in an eQMS/eDMS platform and/or LMS software; experience with WMS/ERP systems is a plus.

KNOWLEDGE, SKILLS & ABILITIES:

Working knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) as applied in a regulated distribution or pharmaceutical environment.
High level of accuracy and attention to detail in document processing, data entry, and record-keeping to maintain inspection-ready quality records.
Demonstrated ability to write clear, accurate documentation entries and assist in drafting training and procedural content.
Strong organizational skills with the ability to manage multiple tasks, prioritize workload, and meet competing deadlines.
Good oral and written communication skills in English; Spanish proficiency is a plus.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); experience with eDMS platforms required.
Intermediate mathematical skills

PHYSICAL DEMANDS:

Frequently required to sit or stand for extended periods; ability to work at a computer for prolonged durations with extensive keyboard and mouse use.
Regularly required to reach, pull, stoop, bend, kneel, and/or crouch as needed within a warehouse or office setting.
Occasionally lift and/or move objects up to 35 lbs.
Expected to support audits remotely or be physically present at the facility as required.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Apply Now

Refine Your Search

document specialist jobs in warren, nj

Sr. Coordinator, Controlled Documentation & Training Compliance (2026-8004)

GMP Document Management

Document Specialist

Document Control Specialist

Senior Quality Specialist (Document Control and Record Management)

Medical Records Technician (Document Imaging)

Specialist, Documentation

Document Specialist

Quality Assurance Specialist - Document Control

Regulatory Documentation Specialist II

Specialist, Quality Document Control

Medicaid Authorization & Documentation Specialist

Senior Consultant - Clinical Documentation Specialist

Specialist, Documentation

Clinical Documentation Specialist HIM

Documentation Review Nurse

Documentation and Training Specialist

Document Control Assistant - 2nd Shift

Document Specialist

Video Documentation Specialist (Part Time)

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