Specialist Manufacturing

World Courier; Juncos (PR); On-site; USD 85,000 - 120,000; Full time

Job summary

World Courier seeks a Specialist Manufacturing on-site in Juncos, PR, to support manufacturing and quality systems across non-conformances, process validation, training, and new product introductions.

With advanced degrees and substantial manufacturing experience, the role involves ownership of process documentation, data review, and execution of CAPA/NC closures while collaborating with process development, quality, and compliance teams.

Qualifications

• Must have strong knowledge of bioprocessing unit operations and GMP production.
• Experience supporting drug substance processes and GMP pharmaceutical systems.
• Ability to communicate and collaborate across manufacturing, process development, and quality teams.
• Experience participating in cross-functional teams and presenting to management.

Responsibilities

• Support execution of manufacturing/quality systems including non-conformances, process validation, procedures, training, and new product introductions.
• Initiate, revise, and approve manufacturing procedures; serve as document owner.
• Assist in process monitoring, CAPA/NC closure, and deviation handling.
• Contribute to process validation protocols and report generation; assist in data analysis.
• Assist with regulatory inspections and NPI/maintenance of documentation systems.
• Support change control and CCRB packages impacting processes.
• Participate in special projects and initiative implementations.

Skills

Bioprocessing understanding

GMP production operations

Regulatory knowledge

Cross-functional leadership

Communication & collaboration

Technical writing

Project management basics

Control charting knowledge

Education

Doctorate degree

Master's degree + 3 years manufacturing ops

Bachelor's degree + 5 years manufacturing ops

Associate's degree + 10 years manufacturing ops

High school diploma / GED + 12 years manufacturing ops

Tools

SAP

TrackWise

PAS/X electronic batch records

Veeva Doc Management

Job description

## Specialist ManufacturingApplylocations: Juncos, Puerto Ricotime type: Full timeposted on: Posted Todayjob requisition id: R2611284Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!# **Job Details****Summary of Role:**With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.**Responsibilities:** Applied Process Expertise* Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.* Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.* Provide troubleshooting support.* Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.Process Monitoring* Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.* Provide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA* Ensure that all Non-conformances are triaged within the established goal.* Responsible for authoring investigation reports.* Responsible for execution of corrective actions.* Responsible for managing NC/CAPA closure within established goal.* Monitor and communicate incidents trends.* Review equipment/system Root Cause Analysis investigations and support trend evaluations.Process Validation* Assist with generation of process validation protocols and reports.* Assist with the execution of the process validation.* Support collection and analysis of process validation data.Regulatory* May participate in regulatory inspectionsNew Product Introductions & Process or Equipment Modifications* Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.* Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.Change Control* Assist manufacturing change owner on CCRB packages impacting the process.Projects and Initiatives* Participate on the assessment or implementation of special projects or initiatives.**Shift:** Administrative**Location:** Juncos, PR**Education:** Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.**Preferred Qualifications:*** Experience in biotechnology pharmaceutical process support, especially on Drug Substance processes, and GMP pharmaceutical manufacturing systems. Knowledge in SAP, TrackWise, electronic batch records (PAS/X) , and documents management systems (Veeva).**Skills:*** Detailed technical understanding of bioprocessing unit operations.* Skilled in performance of GMP production operations.* Regulatory knowledge and interactions.* Participate and help lead cross-functional teams.* Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.* Organizational, technical writing and presentation skills.* Basic project management skills.* Basic knowledge of control charting.This position is for a term contract supporting one of ECHO Consulting Group partners on site at their facility.