Pharma Manufacturing Process Specialist

qualityconsultinggroup

Juncos (PR)

On-site

USD 70,000 - 95,000

Full time

7 days ago

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Job summary

Quality Consulting Group, LLC in Puerto Rico and the USA is seeking a talented, highly motivated Manufacturing Operations professional to join our team and advance world-class manufacturing. You will support manufacturing and quality systems, drive process improvements, and ensure procedures remain current.

This on‑the‑floor role emphasizes NC/CAPA investigations, process validation, NPI, Change Control, and cross‑functional collaboration.

Qualifications

Bachelor’s degree required with 4+ years in Manufacturing Operations.
Direct pharmaceutical/biotech manufacturing experience.
Hands-on floor support in GMP manufacturing environments.
Experience authoring, revising, and approving manufacturing procedures.
Experience with NC/CAPA investigations and closure.
Experience with process validation protocols, execution, and data analysis.
Experience supporting NPI activities and Change Control/CCRB packages.
Experience with process monitoring, trending, and basic control charting techniques.
Experience leading or participating in cross-functional manufacturing improvement projects.
Knowledge of bioprocessing unit operations and GMP manufacturing operations.

Responsibilities

Support execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and NPI.
Apply process, operational, scientific, compliance, analytical, and troubleshooting skills to support manufacturing operations.
Serve as a primary process owner for assigned production process support systems and assist with process ownership for more complex systems.
Initiate, revise, and approve manufacturing procedures to reflect current operations.
Serve as a document owner and ensure procedures remain current and compliant.
Assess process performance through floor observations, data review, and process monitoring.
Identify process improvement opportunities and support implementation of solutions.
Provide technical process troubleshooting support to manufacturing operations.
Develop training materials and provide training on scientific and technical aspects of manufacturing processes.
Support establishment of process monitoring parameters and control limits.
Collect and analyze process monitoring data and support deviation resolution.
Support quarterly process monitoring reports and timely NC/CAPA closure.
Collaborate with cross-functional teams to resolve technical issues.