Specialist Manufacturing Job at ProQualityNetwork in Juncos

Job Title: Specialist Manufacturing

Location: Juncos, PR (100% onsite, open to local candidates in Puerto Rico)

Shift: 8:00 AM 5:00 PM

Positions: 3

Duration: Approximately 1 year

Job Summary

This is a contract opportunity with ProQuality Network to work with our client in a dynamic manufacturing environment. The Specialist Manufacturing will support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and new product introductions.

With minimal supervision, this role applies process and operational expertise, compliance knowledge, and troubleshooting skills to ensure the success of manufacturing operations. The Specialist may serve as a primary process owner for specific systems and assist with ownership of more complex systems.

Educational Requirements

• Doctorate degree OR
• Masters degree with 3 years of Manufacturing Operations experience OR
• Bachelors degree with 5 years of Manufacturing Operations experience OR
• Associates degree with 10 years of Manufacturing Operations experience OR
• High school diploma/GED with 12 years of Manufacturing Operations experience

Preferred Qualifications

• Bachelors degree in Sciences or Engineering
• Expertise in:
• Manufacturing Processes
• Documentation Revision
• CAPA management
• Change Controls

Key Responsibilities

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations. Serve as a document owner.
• Evaluate process performance through floor operations observation and performance data review. Plan and implement process improvement solutions.
• Provide troubleshooting support for manufacturing operations.
• Assist in developing training materials and support training on technical or scientific processes.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits. Collect and analyze monitoring data and assist in deviation assessments.
• Contribute to the timely execution of quarterly process monitoring reports.

Non-Conformance and CAPA Management

• Triage non-conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closures within specified timelines.
• Monitor and communicate incident trends.
• Review root cause analysis investigations and support trend evaluations.

Process Validation

• Assist in generating and executing process validation protocols and reports.
• Support the collection and analysis of validation data.

Regulatory Compliance

• Participate in regulatory inspections, as required.

New Product Introductions & Process Modifications

• Participate in the NPI process to evaluate documentation, material, training, and equipment requirements.
• Assess, prioritize, and support process or equipment modifications.

Change Control

• Assist in managing CCRB packages impacting the manufacturing process.

Projects and Initiatives

• Support the assessment and implementation of special projects and initiatives.

Competencies/Skills

• Strong technical understanding of bioprocessing unit operations.
• Proficient in GMP production operations.
• Knowledge of regulatory compliance and interactions.
• Ability to communicate effectively with technical and management teams.
• Skilled in organizational tasks, technical writing, and presentations.
• Basic project management capabilities.
• Proficiency in control charting and trend analysis.

Why Join Us?

ProQuality Network provides an excellent opportunity to grow your career in a fast-paced, collaborative manufacturing environment. This role allows you to bring your expertise to a meaningful project, supporting innovation and ensuring the quality of products that make a difference.

How to Apply

If youre ready to advance your career and take on a challenging yet rewarding role, we encourage you to apply with an updated resume.

Join us and be a part of impactful change in manufacturing operations!