On-Site Manufacturing Specialist – Process & NPI Lead

ProQuality Network; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, is seeking a Specialist Manufacturing to support manufacturing and quality systems on-site for a 1-year contract. The role focuses on NCRs, CAPA, process validation, NPI, and change control, with responsibilities spanning document ownership, procedure approvals, and cross-functional collaboration.

Responsibilities include monitoring process performance, developing training materials, and participating in regulatory inspections as needed.

Qualifications

• Master’s degree with 3 years of manufacturing ops experience.
• Bachelor’s degree with 5 years of manufacturing ops experience.
• Associate degree with 10 years of manufacturing ops experience.
• High school diploma or GED with 12 years of manufacturing ops experience.
• Detailed technical understanding of bioprocessing unit operations.
• Proficiency in GMP production operations.
• Regulatory knowledge and experience with regulatory interactions.
• Ability to lead cross-functional teams.
• Ability to communicate with technical and management staff across groups.
• Strong organizational, technical writing, and presentation skills.

Responsibilities

• Initiate, revise, and approve manufacturing procedures reflecting current operations.
• Serve as a document owner.
• Assess process performance through floor observations and data reviews.
• Evaluate and implement process improvements.
• Assist in developing training materials and may provide training on process aspects.
• Support process monitoring and quarterly reports.
• Assist in process validation protocols and reports.
• May participate in regulatory inspections.
• Provide NPI process support for documentation, material, training, and equipment modifications.
• Provide implementation and project management support for modification projects.
• Assist with Change Control Review Board packages.

Skills

Manufacturing operations

GMP production operations

Regulatory knowledge

Cross-functional collaboration

Technical writing

Education

Master’s degree

Bachelor’s degree

Associate degree

High school diploma or GED

Job description

ProQuality Network in Juncos, Puerto Rico, is seeking a Specialist Manufacturing to support manufacturing and quality systems on-site for a 1-year contract. The role focuses on NCRs, CAPA, process validation, NPI, and change control, with responsibilities spanning document ownership, procedure approvals, and cross-functional collaboration.

Responsibilities include monitoring process performance, developing training materials, and participating in regulatory inspections as needed.