Documentation SpecialistKatalyst HealthCares & Life Sciences • Ridgefield,, NJ

Documentation Specialist

Katalyst HealthCares & Life Sciences • Ridgefield,, NJ

[job_card.30_days_ago]

[job_preview.job_type]

[job_card.full_time]

[job_card.job_description]

Roles & Responsibilities :

Documentation Management.
Review and verify manufacturing Batch Production Records (BPRs) to ensure compliance with internal specifications, cGMP regulations, and ISO guidelines.
Review production schedules with various departments to ensure alignment and efficiency.
Manage the lifecycle of production documents, including creation, review, approval, and archiving.
Manage the printing, distribution, and tracking of all production-related documentation.
Batch Production Records (BPRs), Bills of Materials (BOMs), Protocols, and Labels for production, ensuring accuracy, traceability and compliance.
Utilize systems such as SAP and other relevant software for documentation and data management.
Cross-functional Collaboration on documentation improvement projects to maintain integrity and compliance.
Liaise with various teams including Quality, Regulatory Affairs, and Supply Chain to ensure seamless information flow.

Education & Experience:

High school diploma or equivalent experience required.
- years in a GMP manufacturing environment
Experience in the pharmaceutical or medical device industry
Knowledge, Skills, Abilities
Strong knowledge of cGMP regulations and ISO standards
Proficiency in Microsoft Office suite
Excellent organizational and communication skills
High school diploma or equivalent experience required.
- years in a GMP manufacturing environment.
Experience in the pharmaceutical or medical device industry.
Strong knowledge of cGMP regulations and ISO standards.
Proficiency in Microsoft Office suite.

[job_alerts.create_a_job]

Documentation Specialist • Ridgefield,, NJ

[internal_linking.similar_jobs]

FIxed Income Document Negotiator - Associate

Morgan Stanley • New York, NY, United States

[job_card.full_time]

Morgan Stanley is a leading global financial services firm providing a wide range of investment banking, securities, investment management and wealth management services.The Firm's employees serve ...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Regulatory Start-Up Specialist

Columbia University • New York, NY, United States

[job_card.full_time]

Job Type: Officer of Administration.The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, e...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Mail Processor - No Experience Required

Postal Jobs Assist • Garnerville, New York, United States

[job_card.full_time]

USPS is accepting applications for PSE Mail Processing Clerks nationwide.This role is vital to ensuring the timely and accurate processing of mail.USPS provides comprehensive training to help you s...[show_more]

[last_updated.last_updated_30] • [promoted]

Correctional Program Specialist (Contract Oversight Specialist)

Justice, Bureau of Prisons/Federal Prison System • New York, NY, United States

[job_card.full_time]

Summary Corrections professionals who foster a humane and secure environment and ensure public safety by preparing individuals for successful reentry into our communities.Responsibilities Assumes r...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

QM & Regulatory Affairs Specialist

Herbstreith & Fox • Ardsley-on-Hudson, NY, United States

[job_card.full_time]

QM & Regulatory Affairs Specialist.This Job Description shows the most important duties of the Quality Management & Regulatory Affairs Specialist at Herbstreith & Fox Inc.The catalogue of jobs may ...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

EDGAR Filing Specialist - Structured Transactions

Morgan Lewis • New York, NY, United States

[job_card.temporary]

Morgan, Lewis & Bockius LLP, one of the world's leading global law firms with offices in strategic hubs of commerce, law, and government across North America, Asia, Europe, and the Middle East, is ...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Customs Specialist

Freight Executives • Carlstadt, NJ, United States

[job_card.full_time]

Our client is an established global logistics partner (3PL) offering customized solutions for complex logistics challenges.They are actively hiring a full-time Customs Entry Writer on-site in Secau...[show_more]

[last_updated.last_updated_less] • [promoted] • [new]

RMF/Cyber Documentation and Reporting Associate

Oneida Technical Solutions • West Point, NY, USA

[job_card.full_time]

[filters_job_card.quick_apply]

Oneida Technical Solutions (OTS) is a tribally-owned 8(a) certified IT Network and Telecommunications Services company, wholly owned and operated by the Oneida Nation of New York through Oneida Nat...[show_more]

[last_updated.last_updated_30]

Plan Documents Specialist - Freelance Project

Meridial Marketplace, by Invisible • New York, NY, United States

[job_card.temporary]

Plan Documents Specialist - Freelance Project.We’re looking for a dedicated specialist to assist our Operations team to manage plan document drafting, amendments, restatements, and plan setup.Prior...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Content Licensing Specialist

McGraw-Hill Education • New York, NY, United States

[job_card.full_time]

McGraw Hill is a diverse and inclusive company that believes we can change the world by leveling the playing field and giving every learner an equal opportunity to succeed.We create best-in-class, ...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Remote Cloud Technical Writer & Documentation Expert

Effectual • Jersey City, NJ, United States

[filters.remote]

[job_card.full_time]

A technology consulting firm is seeking a Technical Writer to create and maintain documentation for cloud-based services.This role involves translating technical information into user-friendly cont...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Regulatory Associate, Member Documents

Oscar Health • New York, NY, United States

[job_card.full_time]

We're hiring a Regulatory Associate, Member Documents (EOC) to join our Regulatory Affairs.Oscar is the first health insurance company built around a full stack technology platform and a relentless...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Regulatory Specialist-CCTO

Weill Cornell Medical College • New York, NY, United States

[job_card.full_time]

Title: Regulatory Specialist-CCTO.As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices.Under general direction, oversees the regulatory aspec...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Clinical Documentation Specialist - Level II

NYC Health Hospitals • New York, NY, United States

[job_card.full_time]

Elmhurst Hospital Center (EHC) is the major tertiary care provider in the borough of Queens.The hospital is comprised of 545 beds and is a Level I Trauma Center, an Emergency Heart Care Station and...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Clinical Documentation Specialist RN

Hackensack Meridian Health • Hackensack, NJ, United States

[job_card.full_time] +1

Our team members are the heart of what makes us better.With a culture rooted in connection and collaboration, our employees are team members.Here, competitive benefits are just the beginning.It's a...[show_more]

[last_updated.last_updated_variable_days] • [promoted]

Recording Specialist

Blackbird Recruiting • New York, NY, United States

[job_card.full_time]

Our client is seeking a Recordings Specialist to join its growing team.This role is ideal for a detail-oriented and organized professional who takes pride in accuracy and follow-through.The Recordi...[show_more]

[last_updated.last_updated_30] • [promoted]

Travel CT Tech - $1,708 to $1,910 per week in Hudson, CT

AlliedTravelCareers • Hudson, CT, US

[job_card.full_time]

AlliedTravelCareers is working with Prime Time Healthcare to find a qualified CT Tech in Hudson, Connecticut!.Now Hiring: Allied Healthcare CT - Hudson, FL.Contact us for Pay Information.Actual amo...[show_more]

[last_updated.last_updated_30] • [promoted]

Business Continuity Specialist

Control Risks • New York, NY, United States

[job_card.full_time]

Control Risks’ Embedded Consulting team is looking for a Business Continuity Analyst to help support a Fortune 100 client's corporate business continuity program focused on the Americas region.The ...[show_more]

[last_updated.last_updated_variable_days] • [promoted]