Specialist Manufacturing - 33814

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.


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.

Function:
Applied Process Expertise
1. Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
2. Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
3. Provide troubleshooting support.
4. Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Process Monitoring
1. Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
2. Provide support of timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA
1. Ensure that all Non-conformances are triaged within the established goal.
2. Responsible for authoring investigation reports.
3. Responsible for execution of corrective actions.
4. Responsible for managing NC/CAPA closure within established goal.
5. Monitor and communicate incidents trends.
6. Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation
1. Assist with generation of process validation protocols and reports.
2. Assist with the execution of the process validation.
3. Support collection and analysis of process validation data.

Regulatory
1. May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications
1. Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control
1. Assist manufacturing change owner on CCRB packages impacting the process.

Preferred Qualification:1- Change Control Management / Project Management experience
2- Implementation of CAPAs | Hands on experience managing CAPAs in manufacturing areas.
3- Deviations documentation when required
4- Experience in Risk ManagementEducation:
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.
• Other functions may be assigned.

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.