Biopharma Manufacturing Specialist: Process & Quality
ProQuality Network
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Job summary
ProQuality Network is seeking a Specialist Manufacturing in Juncos, Puerto Rico to support manufacturing operations and quality systems in a highly regulated biopharmaceutical environment. The role involves process validation, CAPAs, NCs, Change Control, NPI, and continuous improvement activities.
The selected candidate will apply analytical thinking, troubleshooting, and cross-functional collaboration to optimize manufacturing performance while ensuring compliance with cGMP and GDP
Qualifications
- Bachelor's degree in Chemical, Mechanical, Industrial Engineering, Biotechnology or Life Sciences.
- Experience in manufacturing operations in regulated industries.
- Experience with process validation, Change Control, CAPA, investigations.
- Knowledge of cGMP, GDP, and regulatory compliance.
- Strong analytical and communication skills.
Responsibilities
- Author, revise, review, and approve manufacturing procedures while ensuring documentation reflects current operations.
- Monitor manufacturing operations through floor observations and data analysis.
- Support NC/CAPA management and trend analysis.
- Assist in process validation protocols and reports.
- Support regulatory compliance, NPI, and change-control activities.
- Provide technical training materials and support training activities for personnel.
Skills
Education
Job description
ProQuality Network is seeking a Specialist Manufacturing in Juncos, Puerto Rico to support manufacturing operations and quality systems in a highly regulated biopharmaceutical environment. The role involves process validation, CAPAs, NCs, Change Control, NPI, and continuous improvement activities.
The selected candidate will apply analytical thinking, troubleshooting, and cross-functional collaboration to optimize manufacturing performance while ensuring compliance with cGMP and GDP
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