Specialist Manufacturing 35922

Inteldot; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Inteldot in Puerto Rico seeks an Administrative Shift professional to support manufacturing/quality systems with emphasis on CAPA, non-conformances, process validation, and NPI. You will serve as a document owner, drive procedural improvements, and assist in regulatory readiness in collaboration with cross-functional teams.

The role requires strong analytical and troubleshooting skills, effective communication, and the ability to handle multiple stakeholders across sites.

Qualifications

• Knowledge in CAPA/CC/Risk Assessments/CDOC editor.
• Ability to initiate, revise, and approve manufacturing procedures.
• Experience supporting process validation and NPI processes.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; ensure procedures reflect current operations; serve as document owner.
• Assess process performance by observing floor operations and reviewing performance data; plan and implement improvements.
• Provide troubleshooting support for manufacturing operations.
• Assist in generation of training materials and training on scientific/technical aspects.
• Support establishment of process monitoring parameters and control limits; collect data and assess deviations.
• Assist with generation of process validation protocols and reports and execute validation.
• Participate in regulatory inspections, NPI, and process/equipment modifications.

Skills

CAPA/CC/Risk assessments/CDOC editor

Effective communication

Cross-functional collaboration

Education

Doctorate or Master's with 2 years manufacturing ops

Bachelor's with 4 years manufacturing ops

Associate's with 8 years manufacturing ops

High school/GED with 10 years manufacturing ops

Job description

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

Job Description:

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Knowledge & Experience:

• Knowledge in CAPA/CC/Risk Assessments/CDOC editor
• Effective communication, collaboration, and the ability to drive results across multiple stakeholders are essential for success in this role.

Responsibilities:

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA
• Ensure that all non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Assist with generation of process validation protocols and reports and with the execution of the process validation.
• Support collection and analysis of process validation data.
• Participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• Assist manufacturing change owner on CCRB packages impacting the process.
  

Education:

• Doctorate OR Master's degree with 2 years of Manufacturing Operations experience, a bachelor's degree with 4 years of Manufacturing Operations experience, an associate's degree with 8 years of Manufacturing Operations experience, or a High school/GED with 10 years of Manufacturing Operations experience.