Specialist Manufacturing - 33169

Mirus Consulting Group
US - Juncos
May 10, 2024

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

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.
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.
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.
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.
May participate in regulatory inspections
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.
Assist manufacturing change owner on CCRB packages impacting the process.
Participate on the assessment or implementation of special projects or initiatives.

Preferred Qualifications

Project Management and/or Quality Management skills and experience.
Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
Experience managing quality records (deviations (major and minor), CAPAs, CAPA-EV, Change Controls) using TrackWise System
Experience navigating and executing transactions in SAP (ERP) system
Experience managing suppliers. Strong negotiation skills when working with external suppliers and internal team members
Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
Excellent communication skills, both written and verbal (including technical writing and presentation skills) with ability to collaborate productively with technical and senior management staff.
Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.

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.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

Read the full job description and apply online on the recuiter's web-site

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