Regulatory Documentation Specialist - Life Sciences

Mentor Technical Group; Barceloneta (PR); On-site; USD 42,000 - 64,000; Full time

Job summary

Mentor Technical Group (MTG) seeks a documentation and compliance-focused professional in the life sciences sector. The role supports validation activities and ensures adherence to cGMP and ISO 17025:2017, with offices in Puerto Rico and Boston.

You will handle project documentation, SOP reviews, and client-facing support to maintain high-quality services for pharmaceutical, biotechnology, and medical device clients.

Qualifications

• BA in Business Administration.
• Proficient in computer software programs such as word processors, spreadsheets, and databases.
• Basic analytical experience and data management skills.
• Proficient typing skills and attention to detail.

Responsibilities

• Provide technical support and ensure operations comply with corporate/government policies and regulations in a cost-effective way and within customer timelines.
• Perform documentation activities per project assignment and customer requirements and comply with cGMP and safety procedures.
• Review SOPs, Work Instructions and forms to comply with ISO 17025:2017.
• Maintain client communication and monitor project status to meet client requirements.
• Promote positive client relationships and transparent, professional conduct at all times.
• Identify project opportunities by providing technical expertise and alert management to issues.
• Fulfill MTG administrative requirements (time sheets, CV updates, etc.).
• Stay informed on regulatory changes affecting validation in pharmaceutical, biotech, and healthcare industries.

Skills

MS Office

Data organization

Analytical thinking

Typing skills

Education

BA in Business Administration

Job description

Mentor Technical Group (MTG) seeks a documentation and compliance-focused professional in the life sciences sector. The role supports validation activities and ensures adherence to cGMP and ISO 17025:2017, with offices in Puerto Rico and Boston.

You will handle project documentation, SOP reviews, and client-facing support to maintain high-quality services for pharmaceutical, biotechnology, and medical device clients.