Manufacturing Documentation & Compliance Specialist

Mirus Consulting Group; Juncos (PR); On-site; USD 65,000 - 95,000; Full time

Job summary

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Manufacturing to support regulated manufacturing operations by developing, reviewing, and managing manufacturing documentation to ensure compliance with quality and regulatory requirements.

The role partners with operators and cross-functional teams to implement documentation updates, drive process standardization, and assist during audits.

Qualifications

• Experience in Manufacturing Operations within a regulated manufacturing environment.
• Experience in Document Management, including document creation, revision, review, and approval processes.
• Strong understanding of manufacturing procedures, work instructions, and controlled documentation systems.
• Ability to work closely with manufacturing operators and cross-functional teams.
• Strong organizational, communication, and technical writing skills.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency with Microsoft Office applications and electronic document management systems.

Responsibilities

• Create, revise, review, and coordinate the approval of manufacturing documents, including SOPs, Batch Records, Work Instructions, Forms, and related documentation.
• Ensure manufacturing documentation is accurate, compliant, and aligned with current operational practices.
• Collaborate directly with manufacturing operators to gather process information and support document development and updates.
• Support document lifecycle management activities, including creation, revision control, routing, approval, implementation, and archival.
• Partner with Manufacturing, Engineering, Quality, and other functional areas to ensure documentation changes are properly evaluated and implemented.
• Review manufacturing processes and identify opportunities for process standardization and documentation improvements.
• Provide support during audits, inspections, and regulatory assessments by ensuring documents are current and readily available.
• Maintain compliance with company policies, procedures, safety requirements, and applicable regulatory expectations.
• Support operational excellence initiatives and contribute to improving manufacturing performance.

Skills

Manufacturing Operations

Document Management

Technical Writing

Cross-functional Collaboration

MS Office

EDMS

Education

Doctorate Degree

Master's Degree + 2 years Manufacturing Operations experience

Bachelor's Degree + 4 years Manufacturing Operations experience

Job description

mîrus Consulting Group, based in Humacao, Puerto Rico, seeks a Specialist Manufacturing to support regulated manufacturing operations by developing, reviewing, and managing manufacturing documentation to ensure compliance with quality and regulatory requirements.

The role partners with operators and cross-functional teams to implement documentation updates, drive process standardization, and assist during audits.