Senior Investigations & Compliance in Manati at JC Automation Corp

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

About the Role:

The Senior Investigations & Compliance professional plays a critical role in ensuring that the manufacturing operations adhere to all applicable laws, regulations, and internal policies. This position leads complex investigations into potential compliance violations, operational risks, and ethical concerns, providing thorough analysis and actionable recommendations. The role requires collaboration with cross-functional teams to develop and implement compliance programs that mitigate risks and promote a culture of integrity. The successful candidate will be responsible for monitoring regulatory changes and ensuring that the organization’s practices remain current and effective. Ultimately, this role safeguards the company’s reputation and operational continuity by proactively identifying and resolving compliance issues.

Minimum Qualifications:

• Bachelor’s degree in Business Administration, Law, Compliance, or a related field.
• Minimum of 5 years of experience in investigations, compliance, or regulatory roles within the manufacturing industry.
• Strong knowledge of manufacturing regulations, including OSHA, EPA, and industry-specific standards.
• Proven experience conducting complex investigations and managing compliance programs.
• Excellent written and verbal communication skills with the ability to present findings clearly to diverse audiences.

Preferred Qualifications:

• Advanced degree or certification such as Certified Compliance & Ethics Professional (CCEP) or Certified Fraud Examiner (CFE).
• Experience with international manufacturing compliance standards and cross-border regulatory requirements.
• Familiarity with data analytics tools and software used for compliance monitoring and investigations.
• Demonstrated leadership experience managing compliance teams or projects.
• Knowledge of environmental, health, and safety (EHS) management systems.

Responsibilities:

• Lead and conduct detailed investigations into compliance breaches, ethical concerns, and operational irregularities within the manufacturing environment.
• Develop, implement, and maintain comprehensive compliance programs and policies aligned with federal, state, and industry regulations.
• Collaborate with legal, quality assurance, operations, and human resources teams to address compliance risks and ensure corrective actions are executed effectively.
• Monitor regulatory developments and assess their impact on company policies and procedures, ensuring timely updates and training.
• Prepare detailed reports and presentations for senior management and regulatory bodies, summarizing investigation findings and compliance status.
• Ensure that all Quality Events are completed and closed within the established timeframe, using the appropriate tools to prevent recurrence.
• Review and provide input to regulatory submissions applicable to the area of responsibility.
• Lead Quality Events and CAPA trend evaluations.
• Participate in regulatory inspections when necessary
• Support site initiatives and other assignments based on business needs.

Skills:

The required skills enable the candidate to effectively identify, investigate, and resolve compliance issues by applying regulatory knowledge and analytical thinking. Strong communication skills are essential for collaborating with internal teams and reporting findings to leadership and regulatory agencies. Preferred skills such as certification and experience with data analytics enhance the ability to proactively monitor compliance trends and detect potential risks early. Leadership and project management skills support the coordination of cross-functional initiatives and the development of robust compliance programs. Together, these skills ensure the candidate can maintain a culture of compliance and integrity within the manufacturing environment.