Bilingual Document Control Specialist - GMP & Compliance

Veg Group; Carolina (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a detail-oriented Document Control Specialist to manage controlled documents (SOPs, batch records, protocols, forms) and maintain version control in a regulated environment.

You will collaborate with multiple departments and SMEs to prepare, update, and review documents for submission, ensuring compliance with cGMP, FDA, and EMA requirements, while training field personnel and keeping records up to date.

Qualifications

• Bachelor's degree in Science, Pharmacy, Biology, Chemistry, or Business/Administration.
• Minimum 3 years' experience in document control within pharma/biotech/regulatory manufacturing.
• Strong written and verbal communication skills in Spanish and English (bilingual).
• Experience managing controlled documents (SOPs, batch records, protocols, forms) and version control.
• Familiar with regulatory requirements (cGMP, FDA, EMA) and compliant document lifecycle practices.
• Skilled in DMS and Microsoft Office; enterprise QMS tools preferred.
• Ability to review and improve document formats and structure for clarity, compliance, and usability.
• Coordinate and track training on SOPs and document-related procedures; ensure records are maintained.
• Detail-oriented, proofreading/editing skills, able to produce clear documentation.
• Flexible schedule; occasional additional hours.

Responsibilities

• Manage controlled documents (SOPs, batch records, protocols, forms) and maintain version control.
• Work with multiple departments to ensure accuracy and quality of document change processes.
• Work with SMEs to prepare, update, and review for submission of controlled documents.

Skills

Bilingual Spanish/English

Attention to detail

Documentation management

Communication skills

Training coordination

Education

Bachelor's degree in Science/Pharma/Biology/Chemistry/Business/Administration

Tools

Microsoft Office

Document Management Systems (DMS)

Enterprise QMS tools

Job description

Validation & Engineering Group, Inc. seeks a detail-oriented Document Control Specialist to manage controlled documents (SOPs, batch records, protocols, forms) and maintain version control in a regulated environment.

You will collaborate with multiple departments and SMEs to prepare, update, and review documents for submission, ensuring compliance with cGMP, FDA, and EMA requirements, while training field personnel and keeping records up to date.