COMPLIANCE SPECIALIST
On-site · Caguas, Caguas, Puerto Rico
Job Summary
COMPLIANCE SPECIALIST with a strong background in regulatory affairs and quality assurance within regulated industries (pharmaceuticals/biotech/medical devices). Responsible for ensuring adherence to regulatory requirements and internal quality standards, developing and maintaining compliance programs and SOPs, conducting regular audits and risk assessments, guiding cross-department teams on compliance issues, investigating potential non-compliance, implementing corrective actions, leading client meetings, and ensuring continuous improvement in quality processes. The role includes evaluating regulatory impact of deviations, preparing detailed reports, CAPA development, managing external/internal audits, and supporting validation protocol activities. Strong knowledge of FDA CFRs, DEA, Pharmacopeia standards, and quality management systems (TrackWise, TruVault), with excellent analytical, communication, and training capabilities.
Required Qualifications
- Bachelor’s degree in chemistry, Microbiology, Engineering or similar STEM discipline highly preferred
- 3 to 5 years of experience in quality assurance or regulatory affairs within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices)
- Knowledge of federal, state, and local regulatory requirements, including FDA CFRs, DEA, and Pharmacopeia standards
- Preferred knowledge in LIMS, and Quality Management Systems (for example TrackWise, TruVault)
- Proven experience in managing both internal and external audits, including preparing for and responding to audit findings
- Strong understanding of regulatory requirements and quality management systems in a regulated industry
- Excellent analytical and problem-solving skills with experience in deviation analysis and root cause analysis
- Effective communication and leadership skills to facilitate client meetings and cross-department collaboration
- Proficiency in managing audits, investigations, and corrective/preventive actions
- Ability to develop and maintain compliance tracking systems and procedural controls
- Experience in validation protocol creation and review is a plus
- Ability to develop and maintain robust systems for tracking overall services compliance
- Experience leading training sessions on regulatory changes and best practices
Desired Qualifications
- Bachelor's degree in chemistry, Microbiology, Engineering or similar STEM discipline highly preferred
- 3 to 5 years of experience in quality assurance or regulatory affairs within a regulated industry
- Knowledge of federal, state, and local regulatory requirements including FDA CFRs, DEA, and Pharmacopeia standards
- Proficiency with LIMS and Quality Management Systems (e.g., TrackWise, TruVault)
- Auditing experience including preparing for and responding to audit findings
- Strong regulatory knowledge and quality management systems in a regulated industry
- Analytical and problem-solving skills with deviation/root-cause analysis
- Effective communication and leadership to facilitate client meetings and cross-department collaboration
- Experience in audits, investigations, CAPAs, and corrective/preventive actions
- Ability to develop and maintain compliance tracking systems and procedural controls
- Experience with validation protocol creation and review is a plus
- Ability to lead trainings on regulatory changes and best practices in quality assurance
- Experience coordinating external/internal audits and ensuring regulatory compliance across multiple departments
- Knowledge of international, federal, state, and local regulatory requirements (FDA CFRs, DEA) and customer requirements
- Capability to evaluate regulatory impact of deviations and compile detailed reports and recommendations
- Strong documentation and record-keeping practices for regulatory compliance
- Ability to stay updated on regulatory changes and drive continuous quality improvements
- Leadership and collaboration across teams to drive compliance initiatives
- Experience with CAPAs and corrective actions to address root causes
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