Compliance Specialist
Compliance Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico the United Sates Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Overview:
We are seeking a Compliance Specialist to serve as the designated Compliance Officer for a high-impact IT service contract supporting operations in the Life Sciences industry. The selected candidate will be responsible for ensuring that all services provided under the contract align with applicable regulatory requirements client policies and industry best practices.
Key Responsibilities:
- Serve as the point of contact for all compliance-related matters under the IT service agreement.
- Ensure adherence to applicable regulations such as FDA 21 CFR Part 11 GxP and data integrity standards.
- Monitor execution of services to ensure they comply with the terms of the contract company policies and regulatory expectations.
- Conduct internal audits and gap assessments related to IT system operations documentation and change control processes.
- Support the development and review of Standard Operating Procedures (SOPs) Work Instructions and Quality Agreements.
- Review incident reports deviations and CAPAs related to IT systems and recommend remediation actions.
- Facilitate training and awareness initiatives to maintain a strong compliance culture within the team.
- Collaborate with Quality IT and client stakeholders to drive continuous improvement and audit readiness.
Qualifications:
- Bachelors degree in Life Sciences Engineering Computer Science or related field.
- Minimum 5 years of compliance experience in a regulated environment (GxP FDA ISO).
- Experience supporting IT operations or services in a Life Sciences environment.
- Knowledge of IT system validation data integrity and computerized systems compliance.
- Strong analytical organizational and communication skills.
- Bilingual (English/Spanish) preferred.
Preferred Experience:
- Prior experience serving as a Compliance Officer or QA Lead in IT/OT projects.
- Familiarity with Manufacturing Execution Systems (MES) Data Historians or validated IT infrastructure.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
