Technical Writer (CAPA Specialist)

Job Description: Technical Writer (CAPA Specialist)

Location: Costa Rica Modality: On-site

Job Objective

We are looking for Technical Writers with experience in regulated environments to support the creation, review, and maintenance of technical documentation related to quality systems. The person will be responsible for documenting investigations, CAPAs, deviations, procedures, and other quality records, ensuring compliance with regulatory standards and internal policies. Based on experiences found in internal documentation of Technical Writers with exposure to CAPA, GMP, investigations, and quality documentation.

Main Responsibilities

• Draft, review, and update technical and quality documentation.
• Prepare and follow up on documentation associated with:
• oCAPAs (Corrective and Preventive Actions)
• oQuality investigations
• oDeviations
• o Change controls
• o SOPs (Standard Operating Procedures)
• oWork instructions
• oQuality forms and records
• Collaborate with Quality, Manufacturing, Engineering, and Regulatory Affairs teams to gather technical information.
• Ensure all documentation complies with regulatory requirements, GMP, and corporate policies.
• Participate in continuous improvement and documentation optimization initiatives.
• Support internal and external audits by providing documentation and evidence of compliance.
• Maintain version control and documentation integrity within electronic quality systems.

Requirements

• Bachelor's or Licentiate degree in Engineering, Life Sciences, Biotechnology, Chemistry, Microbiology, Pharmacy, or a related field.
• Minimum 2 years of experience as a Technical Writer or in functions related to quality documentation.
• Proven experience working with CAPA processes, investigations, and/or deviations.
• Experience drafting technical documentation in regulated environments (medical, pharmaceutical, or regulated manufacturing industry).
• Intermediate English level (B1-B2), with the ability to read, understand, and draft technical documentation.

Desirable Requirements

• Experience in the medical device, pharmaceutical, or life sciences industry.
• Knowledge of ISO 13485, FDA, or 21 CFR Part 820.
• Experience with electronic document management or quality systems (TrackWise, Veeva, MasterControl, among others).
• Experience in validation documentation (IQ, OQ, PQ).

-Requirements-

Minimum education: Bachelor's / High School 1 year of experience

Keywords: escritor, writer, redactor, specialist, especialista