Contract Manufacturing Specialist: Process Excellence

ProQuality Network; Juncos (PR); Hybrid; USD 55,000 - 99,000; Full time

Job summary

ProQuality Network is seeking an experienced Manufacturing Specialist to support pharmaceutical/biotech operations in a regulated environment. This 6-month contract onsite focuses on manufacturing and quality processes, including non-conformances, process validation, and NPI.

The ideal candidate will have a bachelor’s with 4+ years in pharma manufacturing, strong data analysis and change control experience, and familiarity with EBRs and cGMPs.

Qualifications

• Bachelor's degree with 4+ years of pharmaceutical or biotechnology manufacturing experience.
• Experience creating, revising, and approving manufacturing procedures as document owner.
• Familiarity with cGMP regulations and regulatory requirements.
• Experience supporting process validation and calibration activities.

Responsibilities

• Initiate and update manufacturing procedures to reflect current operations.
• Monitor operations and analyze process performance for improvements.
• Lead NC/CAPA investigations and closure activities within deadlines.
• Support NPI, regulatory inspections, and CCRB processes.
• Provide technical troubleshooting and cross-functional training materials.

Skills

GMP knowledge

Data analysis

Technical troubleshooting

Cross-functional collaboration

Training material development

Education

Bachelor's degree in a related field

Master's degree in related field

Associate degree + 8+ years experience

High School Diploma/GED + 10+ years experience

Tools

EBR systems

Regulatory documentation tooling

Job description

ProQuality Network is seeking an experienced Manufacturing Specialist to support pharmaceutical/biotech operations in a regulated environment. This 6-month contract onsite focuses on manufacturing and quality processes, including non-conformances, process validation, and NPI.

The ideal candidate will have a bachelor’s with 4+ years in pharma manufacturing, strong data analysis and change control experience, and familiarity with EBRs and cGMPs.