Document Control Specialist

Make Your Mark in Pharma & Biotech

Keep vital pharmaceutical and biotech operations running smoothly by managing, reviewing, and safeguarding controlled documents that drive industry excellence.

Take on a role where precision and compliance meet global opportunity.

With international exposure in the pharmaceutical and biotechnology industry, this is your chance to grow your career, make an impact on global health, and leave a lasting professional legacy-all while staying rooted in Colombia.

Job Description

As a
Document Control Specialist
, you will manage the lifecycle of controlled documents, partner with SMEs, support audits, and maintain compliance with industry standards.

You will ensure document accuracy, accessibility, and readiness to meet both internal and regulatory requirements.

Job Overview

Employment type: Indefinite term type contract

Shift: Day Shift, Monday-Friday, 9 AM-6 PM CST

Work setup: Hybrid, Calle 97A Bogotá

Exciting Perks Await

• 5 days work week
• Weekends off
• Hybrid work arrangement
• 20 vacation days in total
• Prepaid medicine
• Fully-customized Emapta laptop and peripherals
• Indefinite term type contract
• Direct exposure to our clients
• Career growth opportunities
• Diverse and supportive work environment
• Prime office locations - Bogotá and Medellín
• Unlimited upskilling through Emapta Academy courses (Want to know more?
  
  Visit
  )

The Qualifications We Seek

• Bachelor's degree
  in a relevant field
• 3-5 years of experience
  in
  document control or related role
• Competence in
  FDA, cGMPs, and ICH Q8(R2), Q9, Q10 guidance
  preferred
• Proficiency in Microsoft Office
  (Excel, Word, Visio, PowerPoint, Windows)
• Working knowledge of
  Oracle and Agile systems
• Excellent verbal and written communication skills
• Flexible, self-motivated, and detail-oriented professional
• Ability to work independently, multi-task, and resolve problems efficiently
• Strong team player with the ability to collaborate across all levels of the organization

Your Daily Tasks

• Partner with SMEs to review controlled documents regularly
• Track and trend Quality Policies, SOPs, and WI's pending review
• Review, track, and close CRNs in Agile for controlled documents
• Verify and update controlled document content when CRN is initiated
• Support audits from a document control perspective (remote and in-person)
• Run reports for specific controlled document training in LMS
• Perform in-person GMP training as backup when required
• Route changes for CMOs and support other workflows as needed
• File and maintain physical copies of controlled documents, ensuring retention policy compliance
• Coordinate destruction of documents past retention dates for corporate and SC facilities
• Provide additional quality projects and support as directed by the Quality Systems Manager

About the Client

Our client is
a leading pharmaceutical and biotechnology solutions provider
dedicated to improving patient outcomes through innovation, precision, and compliance.

With decades of expertise and a commitment to the highest quality standards, they design, manufacture, and deliver essential healthcare products worldwide.

By joining their team, you contribute to global health while working alongside experts passionate about making a difference in people's lives.

Welcome to Emapta Colombia

At Emapta, you're not just joining an industry-leading outsourcing provider; you're becoming part of a community that celebrates the rich cultural tapestry of Colombia.

Our track record of success and diverse international clientele across various industries provide a solid foundation for your career.

With over 800 global partners preferring to open remote jobs in the country, our vision is to help you and thousands more Colombians reach your full potential and dreams without the need to leave the country and work abroad.

Join forces with passionate professionals who share the desire to make a meaningful impact through premium global opportunities, all at your fingertips.

Emapta isn't just a company; it's a community that values the balance between work and life.

Start a truly exciting journey with us and discover how your talent can flourish in a setting that celebrates the spirit of Latin America.

EmaptaEra