Biotech Manufacturing Specialist: Process & Quality

Inteldot; Juncos (PR); On-site; USD 65,000 - 100,000; Full time

Job summary

Inteldot in Puerto Rico seeks an Administrative Shift candidate to support manufacturing and quality systems, including deviations, change control, procedures, training, and new product introductions, under minimal supervision.

You will act as document owner, analyze process performance, provide troubleshooting, generate training materials, monitor process parameters, and support regulatory inspections and NPI activities.

Qualifications

• Deviations management and assessments
• Use of Trackwise
• 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, 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.

Skills

Biotech and manufacturing experience

Education

Master’s + 2 years of Manufacturing Operations experience

Bachelor's degree in engineering is a plus

Associates + 8 years of Manufacturing Operations experience

High school/GED + 10 years of Manufacturing Operations experience

Tools

Trackwise

Job description

Inteldot in Puerto Rico seeks an Administrative Shift candidate to support manufacturing and quality systems, including deviations, change control, procedures, training, and new product introductions, under minimal supervision.

You will act as document owner, analyze process performance, provide troubleshooting, generate training materials, monitor process parameters, and support regulatory inspections and NPI activities.