GMP Manufacturing Specialist: Process & Quality

ProQuality Network; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, is seeking a Manufacturing Specialist for an initial 6-month contract. The role demands independent work and strong expertise in manufacturing operations, quality systems, and NPI activities.

You will ensure procedures reflect current operations, support CAPA, and assist with process validation and regulatory readiness. The ideal candidate will apply bioprocessing knowledge and GMP experience to maintain product quality, drive continuous improvement,

Qualifications

• Candidates must meet one of the listed degree/experience combinations.
• Experience in GMP manufacturing environments preferred.
• Strong technical writing and documentation skills required.

Responsibilities

• Initiate, revise, and approve manufacturing procedures ensuring current operations are reflected.
• Owner of procedures and compliance with cGMP and regulatory requirements.
• Evaluate process performance from floor observations and data reviews.
• Identify improvement opportunities and support solutions implementation.
• Provide technical troubleshooting support for manufacturing operations.
• Develop training materials and deliver training on manufacturing processes.
• Ensure process risks are identified and mitigated to protect product quality.
• Maintain Electronic Batch Records aligned with current processes and training.
• Set up process monitoring parameters and control limits; analyze data.
• Support non-conformance and CAPA activities including investigations and closures.
• Review Root Cause Analysis and trend evaluations for equipment and systems.
• Assist with protocol development and data analysis for process validation.
• Participate in regulatory inspections, NPI, and modification projects.
• Support NPI by assessing documentation, materials, and equipment needs.
• Assess and support modification projects, including basic project management.

Skills

Bioprocessing knowledge

GMP manufacturing

Cross-functional collaboration

Technical writing

Problem solving

Independent work

Process validation

CAPA experience

Education

Doctorate in relevant discipline

Master's degree + 2 years Manufacturing Operations experience

Bachelor's degree + 4 years Manufacturing Operations experience

Associate degree + 8 years Manufacturing Operations experience

High school diploma/GED + 10 years Manufacturing Operations experience

Job description

ProQuality Network in Juncos, Puerto Rico, is seeking a Manufacturing Specialist for an initial 6-month contract. The role demands independent work and strong expertise in manufacturing operations, quality systems, and NPI activities.

You will ensure procedures reflect current operations, support CAPA, and assist with process validation and regulatory readiness. The ideal candidate will apply bioprocessing knowledge and GMP experience to maintain product quality, drive continuous improvement,