Specialist Manufacturing Job at BioPharma Consulting JAD Group in Juncos

Summary:
With minimal supervision, the Manufacturing Specialist will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions. The role requires applying process expertise, compliance knowledge, and analytical skills to support manufacturing operations effectively. This position may act as the primary process owner for specific systems and assist with more complex process ownership responsibilities.

Responsibilities:

Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations.

• Serve as a document owner for manufacturing procedures.
• Evaluate floor operations and performance data to identify and implement process improvements.
• Provide troubleshooting support and assist in training material development.
• Support the establishment and assessment of process monitoring parameters and control limits.
• Collect process monitoring data and assist with quarterly report execution.
• Ensure timely triage of non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within designated timelines and monitor trends.
• Support root cause analysis (RCA) and trend evaluations for equipment/system investigations.
• Assist with the creation and execution of process validation protocols and reports.
• Collect and analyze process validation data.
• Participate in regulatory inspections as needed.
• Assess documentation, materials, training, and equipment modification requirements for NPIs.
• Provide project management support for process and equipment modifications.
• Assist in managing Change Control Review Board (CCRB) packages that impact manufacturing processes.
• Contribute to special projects and process improvement initiatives as assigned.

Skills:

• In-depth understanding of bioprocessing unit operations and GMP production.
• Familiarity with regulatory requirements and inspection processes.
• Strong skills in technical writing, organizational tasks, and presentations.
• Ability to collaborate with cross-functional teams, including manufacturing, process development, and quality.
• Basic project management and control charting knowledge.

Requirements

Qualification:

• Doctorate degree OR
• Master’s degree with 3 years of Manufacturing Operations experience OR
• Bachelor’s degree with 5 years of Manufacturing Operations experience OR
• Associate’s degree with 10 years of Manufacturing Operations experience OR
• High school diploma/GED with 12 years of Manufacturing Operations experience.

Preferred Qualifications:

• Bachelor’s Degree in Sciences or Engineering.
• Experience with manufacturing processes, documentation revision, CAPA management, and change control systems.