Senior Quality Assurance Manager

hace 6 días


Juncos, Puerto Rico Cis International Llc A tiempo completo

Job Title:

Senior Quality Assurance Manager

Location: Cis International Llc (Assumed)

Job Description:

The Senior Quality Assurance Manager will be responsible for ensuring the quality of our products and processes. This includes reviewing and approving product masters, process validation protocols, and reports for manufacturing processes.

The successful candidate will also request Quality on incident triage team, approve Environmental Characterization reports, release sanitary utility systems, approve planned incidents, represent QA on NPI team, lead investigations, lead site audits, own site quality program procedures, and designee for QA manager on local CCRB.

In addition, the Senior Quality Assurance Manager will review Risk Assessments, support Automation activities, support facilities and environmental programs, review and approve Work Orders, review and approve EMS/BMS alarms, approve NC investigations and CAPA records, approve change controls, and provide lot disposition and authorize lots for shipment.

Requirements:

We are seeking a highly qualified individual with a Doctorate degree, Master's degree and 3 years of directly related experience, or a Bachelor's degree in Science or Engineering and 5 years of directly related experience, or an Associate's degree and 10 years of directly related experience, or a High school diploma / GED and 12 years of directly related experience.

Preferred Qualifications:

A Quality Professional with Manufacturing Process Audit and Batch Record Review experience is preferred. Additionally, some knowledge or familiarity with DAI process, PASx/MES application, MAXIMO, SAP and LIMS is beneficial.

Work Methodology:

This position requires 100% On-site work, available for non-standard shift which includes nights and weekends. The contract duration is 2 years.

Estimated Salary Range:

$120,000 - $180,000 per year, depending on location and experience.



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