Document Control Specialist

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. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Document Control Specialist

Description:

• 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 SME's to prepare, update, and review for submission of controlled documents.

Qualifications:

• Bachelor's degree in Science, Pharmacy, Biology, Chemistry, or Business/Administration.
• Minimum 3 years' experience in document control within the pharmaceutical, biotech, or regulated manufacturing environment.
• Strong written and verbal communication skills in both Spanish and English (bilingual).
• Proven experience managing controlled documents (SOPs, batch records, protocols, forms) and maintaining version control.
• Familiar with regulatory requirements (cGMP, FDA, EMA) and compliant document lifecycle practices.
• Skilled in document management systems (DMS) and Microsoft Office (Word, Excel, PowerPoint); experience with 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 field resources are trained and records are maintained.
• Detail-oriented, excellent proofreading/editing skills, and capable of producing clear, professional documentation.
• Flexible schedule; willing to work occasional additional hours and rarely on Saturdays when required to meet project deadlines or support critical activities.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.