Summary
Overview
Work History
Education
Skills
Websites
Affiliations
Timeline
Generic
Maria Kalra

Maria Kalra

South Brunswick, NJ

Summary

GMP Documentation & Training Manager experienced in streamlining procedural document processes, leading EDMS transitions, and strengthening quality systems. Skilled in developing impactful training programs, optimizing workflows, and supporting cross‑functional teams. Known for strong attention to detail, problem‑solving, and driving continuous improvement in a compliant, fast‑paced environment.

Overview

14
14
years of professional experience

Work History

Manager, GMP Documentation and Training

Bristol-Myers Squibb
New Brunswick, NJ
10.2023 - Current

Procedures & Document Management

  • Run an efficient procedures management system ensuring 100% on‑time periodic reviews, adherence to defined processes, and alignment with governing QMS requirements.
  • Collaborate with cross‑functional teams to optimize documentation workflows and streamline review and approval cycles.
  • Extensive experience writing, reviewing, and revising procedural documents, following established templates, metadata requirements, and workflow processes.
  • Strong skills in formatting, technical proofreading, and ensuring compliance with BMS documentation standards.
  • Deep knowledge of GMP documentation requirements, including document lifecycle management, training impact assessment, and version control.

Electronic Document Management Systems (EDMS)

  • Proficient in QUMAS and Veeva Vault workflows, including document creation, routing, approval, and training assignment processes.
  • Serve as a change agent during major EDMS transitions, supporting user readiness and business continuity.
  • Conduct User Acceptance Testing (UAT) for new EDMS implementations and enhancements.
  • Develop tools and resources to support adoption of new EDMS functionalities and procedural changes.

Training & Learning Management

  • Drive continuous improvement in training effectiveness, strengthening onboarding, recurrent training, and inspection readiness aligned with global QMS training requirements.
  • Subject Matter Expert (SME) in SuccessFactors, including learning plan management, curricula creation, training assignment, and compliance reporting.
  • Develop comprehensive training curricula tailored to multiple organizational roles.
  • Create, update, and manage training items, curricula assignments, due dates, and procedural training alignment with effective dates.
  • Deliver in‑person training sessions, classroom instruction, and department-wide office hours to support learning and system adoption.
  • Manage and report monthly on‑time training metrics for departmental compliance.

Leadership & Team Support

  • Manage junior contractors responsible for document control and training administration processes.
  • Provide coaching and support for onboarding and offboarding, ensuring training and procedural alignment for new and departing staff.
  • Train colleagues on their responsibilities in the procedural document process and EDMS workflows.

Process Improvement & Collaboration

  • Participate in best‑practice teams to evaluate procedures and training programs, benchmark external/internal standards, and recommend enhancements.
  • Extensive experience in SharePoint design, supporting collaboration, document access, and workflow visibility.

Compliance & Core Behaviors

  • Consistently adhere to BMS core behaviors, ethics, and GMP compliance requirements in all documentation and training activities.

Senior Specialist GMP Procedures and Training

Bristol-Myers Squibb
New Brunswick, NJ
07.2020 - 10.2023
  • Partner with procedures manager to run an efficient procedures management system with on time periodic reviews and defined processes.
  • Manage procedures lists with SME, reviewers, approvers, process steps and due dates. Schedule procedure discussion meetings, prepare agenda and minutes.
  • Prepare procedural document management workflows for various types of documents in compliance with procedures and training.
  • Apply the Quality Management Document hierarchy in alignment with PD and department practices.
  • Complete all training on time and achieve required document or training administration role skills and responsibilities.
  • Maintain procedure title, type and numbering as per department practice.
  • Format procedural documents according to guidelines.

Document Specialist

All Source PPS Bristol-Myers Squibb
New Brunswick, NJ
10.2018 - 07.2020
  • Follow good document management for both paper and electronic files and data bases.
  • Keep data safe and readily available.
  • Excellent Accuracy in inputting and retrieving information from documentation applications.
  • Respond to customer document management requests in a timely manner.
  • Perform and assist with record retention duties and support of established record retention procedures and policies.

Document Control Coordinator

MTS Solutions PSEG
Newark, NJ
07.2017 - 09.2017
  • Responsible for coding vital engineering documents.
  • Review the accuracy of blueprints.
  • Manage documents and ensure records are properly stored and accessible. Exercise excellent communication skills.
  • Resolve complications in a quick and timely manner.

Front Desk Receptionist/File Clerk

The Princeton Eye Group
Somerset & Princeton, NJ
02.2014 - 10.2016
  • Pulled patient charts for upcoming appointments.
  • Typed medical orders for procedures and laboratory tests.
  • Scanned incoming documentation.
  • Followed-up with insurance companies and individuals to resolve discrepancies.
  • Maintained complete confidentiality in accordance with organization and legal requirements.

Manager

Caddyshack Bar & Grill
Plainsboro, NJ
04.2012 - 07.2017
  • Recruit, hire, train, and schedule bartenders and barbacks.
  • Provide ongoing coaching to maintain service quality and adherence to policies.
  • Conduct performance evaluations and address employee concerns or discipline issues.
  • Monitor inventory levels and manage ordering of beverages, supplies, and equipment.
  • Ensure guests receive excellent service and resolve customer complaints promptly.
  • Create a welcoming atmosphere aligned with the venue’s brand.
  • Oversee responsible alcohol service and ensure all staff follow regulations.
  • Manage bar budgets, cost controls, and profit margins.
  • Track sales, forecast demand, and monitor beverage costs to reduce waste.
  • Handle cash management, deposits, and POS oversight

Education

Associates of Arts - Liberal Arts

Middlesex County College
Edison, NJ
01.2013

Bachelor’s Degree - Business Administration

Rutgers University
08-2026

Skills

  • Proficient in Microsoft Office Suite, Share Point, and Visio
  • Quality Management System (QMS) knowledge, including document control and audit readiness
  • Regulatory and compliance awareness (ICH, GxP, industry standards)
  • Risk assessment & change control support
  • Subject Matter Expert in QUMAS, Success Factors, and Veeva Vault
  • Leadership and team coordination
  • Detail Orientated
  • Highly organized
  • Strong analytical and problem-solving skills to address challenges in documentation and training

Affiliations

Bristol Myers Squibb Network of Women (B-NOW)

Cultivating Leadership, Innovation & Multigenerational Belonging (CLIMB)

Timeline

Manager, GMP Documentation and Training

Bristol-Myers Squibb
10.2023 - Current

Senior Specialist GMP Procedures and Training

Bristol-Myers Squibb
07.2020 - 10.2023

Document Specialist

All Source PPS Bristol-Myers Squibb
10.2018 - 07.2020

Document Control Coordinator

MTS Solutions PSEG
07.2017 - 09.2017

Front Desk Receptionist/File Clerk

The Princeton Eye Group
02.2014 - 10.2016

Manager

Caddyshack Bar & Grill
04.2012 - 07.2017

Associates of Arts - Liberal Arts

Middlesex County College

Bachelor’s Degree - Business Administration

Rutgers University