Specialist Manufacturing 35510

Inteldot; Juncos (PR); On-site; USD 95,000 - 120,000; Full time

Job summary

Inteldot is seeking an Administrative Shift role in Puerto Rico to support manufacturing and quality systems. You will handle deviations, assessments, and document control, while assisting with process validation, NPI, and training materials. The role requires biotech/manufacturing experience and familiarity with TrackWise.

The position involves cross-functional collaboration to ensure compliant operations, with potential for overtime based on business demand.

Qualifications

• Experience managing deviations and deviation assessments.
• Experience with TrackWise and biotech/manufacturing environments.
• Familiarity with manufacturing quality systems and GMP practices.

Responsibilities

• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assess process performance and implement improvements based on data and observations.
• Provide troubleshooting support for manufacturing operations.
• Assist in generating training materials and delivering training on process aspects.
• Support establishment of process monitoring parameters and control limits.
• Prepare and review process validation protocols and reports.
• Participate in NPI processes to assess documentation, materials, and equipment needs.
• Support CCRB packages and change control related to processes.

Skills

Deviations management

Deviation assessments

Biotech and manufacturing experience

Education

Doctorate

Master’s degree

Bachelor's degree

Associates degree

High school/GED

Tools

TrackWise

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 (Overtime may be required based on business demand)

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.

Requirements

Experience in:

1. Deviations management
2. Deviation assessments
3. Track wise
4. Biotech and manufacturing experience

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.
• Responsible for execution of corrective actions.
• Responsible for 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.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.
• 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.
• Participate on the assessment or implementation of special projects or initiatives

Education

1. Doctorate OR Master’s + 2 years of Manufacturing Operations experience OR Bachelors + 4 years of Manufacturing Operations experience OR Associates + 8 years of Manufacturing Operations experience OR High school/GED + 10 years of Manufacturing Operations experience.