Manufacturing Specialist 35455

ProQuality Network; Juncos (PR); Hybrid; USD 70,000 - 100,000; Full time

Job summary

ProQuality Network seeks a Specialist Manufacturing for onsite work in a GMP-regulated environment. The role focuses on supporting manufacturing processes, CAPA/NC management, change control, and continuous improvement projects.

Collaboration with Process Development, Engineering, and Quality is essential for success. The candidate will handle non-conformances, CAPAs, change control, process validation, training, and documentation, with strong analytical and technical writing skills required.

Qualifications

• Must meet one of the listed education/experience combinations.
• Experience in manufacturing ops in a regulated GMP environment is preferred.
• Strong knowledge of quality systems and regulatory requirements.

Responsibilities

• Support manufacturing processes and document control, ensure procedures reflect current operations.
• Monitor processes with data analysis and reporting.
• Lead NC/CAPA activities and trend monitoring.
• Assist with process validation protocols and reports.
• Support regulatory inspections and NPI activities.
• Participate in continuous improvement projects.

Skills

Bioprocessing

GMP experience

Cross-functional collaboration

Technical writing

Analytical thinking

Process optimization

Regulatory knowledge

Quality systems

Education

Master's degree + 2 yrs manufacturing ops

Bachelor's degree + 4 yrs manufacturing ops

Associate degree + 8 yrs manufacturing ops

High School Diploma or GED + 10 yrs manufacturing ops

Tools

CAPA management

Change Control

SOP development

Process validation

Job description

Title: Specialist Manufacturing – Job ID 35455

Work Schedule: Onsite | 8-hour non-standard shifts

Contract Duration: 6 Months

Position Summary

Our client is seeking a Specialist Manufacturing to support manufacturing operations and quality systems within a GMP-regulated environment. This position requires a professional who can work with minimal supervision while providing technical support for manufacturing processes, process improvements, quality systems, and operational excellence initiatives.

The selected candidate will support activities related to non-conformances, CAPAs, change control, process validation, training, documentation, and new product introductions. This role also requires strong analytical, troubleshooting, and technical writing skills, as well as the ability to collaborate effectively with cross-functional teams.

Preferred Qualifications

• Bachelor's or advanced degree in Science or Engineering is preferred.
• Experience supporting manufacturing operations in a regulated environment.
• Experience working with manufacturing procedures and controlled documentation.
• Hands-on experience with:
• CAPA and CAPA Effectiveness Verification (CAPA EV)
• Change Control
• SOP development and revisions
• Process improvements and continuous improvement initiatives
• Implementation of new manufacturing processes
• Operator training and technical support

Key Responsibilities

Manufacturing Process Support

• Initiate, revise, and approve manufacturing procedures while ensuring documentation accurately reflects current operations.
• Serve as the owner of manufacturing documents and controlled procedures.
• Evaluate manufacturing process performance through production floor observations and data analysis.
• Identify process improvement opportunities and implement effective solutions.
• Provide technical troubleshooting support for manufacturing operations.
• Develop training materials and provide technical or scientific training to manufacturing personnel when required.

Process Monitoring

• Support the establishment of process monitoring parameters and control limits.
• Collect, review, and analyze process monitoring data.
• Assist in the evaluation of process deviations and recommend corrective actions.
• Support the timely preparation and completion of quarterly process monitoring reports.

Non-Conformance (NC) and CAPA Management

• Ensure all non-conformances are triaged within established timelines.
• Author investigation reports for manufacturing events and deviations.
• Execute corrective and preventive actions (CAPAs).
• Manage NC and CAPA activities through closure within established deadlines.
• Monitor and communicate trends related to manufacturing incidents.
• Review Root Cause Analysis (RCA) investigations for equipment and systems and support trend analysis.

Process Validation

• Assist in developing process validation protocols and reports.
• Support execution of process validation activities.
• Collect, review, and analyze process validation data.

Regulatory Support

• Participate in regulatory inspections as needed.
• Support New Product Introduction (NPI) activities.
• Assist with documentation, training, material assessments, and equipment modifications required for new products.
• Evaluate, prioritize, justify, and support implementation of manufacturing process or equipment modification projects.

Change Control

• Support the Manufacturing Change Owner with Change Control Review Board (CCRB) packages impacting manufacturing processes.

Projects and Continuous Improvement

• Participate in special projects and operational improvement initiatives.
• Provide project support related to manufacturing, quality, and process optimization.
• Perform additional responsibilities as assigned.

Minimum Education and Experience

Candidates must meet one of the following qualifications:

• Master's degree with 2 years of Manufacturing Operations experience
• Bachelor's degree with 4 years of Manufacturing Operations experience
• Associate degree with 8 years of Manufacturing Operations experience
• High School Diploma or GED with 10 years of Manufacturing Operations experience

Required Knowledge and Skills

• Strong understanding of bioprocessing unit operations.
• Experience performing manufacturing activities in a GMP-regulated environment.
• Working knowledge of regulatory requirements applicable to pharmaceutical or biotechnology manufacturing.
• Experience participating in cross-functional teams.
• Strong communication and collaboration skills with Manufacturing, Process Development, Engineering, and Quality organizations.
• Excellent organizational, technical writing, and presentation skills.
• Basic project management knowledge.
• Knowledge of statistical process monitoring and control charting.
• Strong analytical thinking and problem-solving abilities.
• Ability to identify opportunities for continuous process improvement while maintaining compliance with quality and regulatory standards.