QMS Specialist 1

United States·Lombardmid

OtherEhs Specialist

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Quick Summary

Overview

Requirements Summary

High School Diploma, GED or equivalent. 5+ years of related experience in a manufacturing regulated industry. Background with implementation of process improvement programs. Strong computer skills including Microsoft Office suite.

Technical Tools

excelms-office

The Quality Management Systems Specialist will work with site employees to ensure bioMerieux’s standards and requirements are met for various Quality systems. The position will act as administrator for batch record review, document control, training, and audits. Specialist will also support in the completion of higher criticality Quality tasks such as Quality Events, CAPAs, and metrics in association with bioMerieux’s policies.

Primary Duties & Responsibilities

Perform Quality review of lot batch records for good documentation requirements and paperwork meets process specifications for product release.
Process release of lots per Quality assurance procedures.
Coordinate Change Request workflows and publish controlled documents within Document Control system, LLDC.
Coordinates internal and external audit schedule with stakeholders.
Oversee the learning management system. Log completed training, generate reports and optimize training requirements for management.
Supports site continuous improvement activities.
Supports activities related to Quality Events and CAPA activities.
Provides input for improvement in the Quality Management System.
Support Quality Engineers with determination of Key Performance Indicators.
Performs initial review of all Corporate driven procedure changes and manages Corporate Document Change Impact process.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.

Required Qualifications

High School Diploma, GED or equivalent.
5+ years of related experience in a manufacturing regulated industry.

Preferred Qualifications

Background with implementation of process improvement programs.
Strong computer skills including Microsoft Office suite.
Knowledge of ISO 9001 preferred.
Experience with SAP a plus.
Experience in Quality, preferably with a GMP.

Knowledge, Skills, and Abilities

Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives.
Effective verbal communication skills.
Demonstrates assertiveness and confidence in the face of a challenge.
Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
Functional skills including critical thinking, adaptability, time management, communication, problem-solving and digital literacy.
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel; applies skills independently in most situations and handles moderately complex tasks with occasional guidance.
Functionally required knowledge, skills, and abilities as needed for the role.

Working Conditions & Physical Requirements

Ability to remain in a stationary position, either sitting or standing, for prolonged periods. Ability to adjust or move objects up to 20 pounds in all directions.

Some travel Domestic travel: 10%. International travel: 5% may be required.

The estimated wage range for this role based in Illinois is between $26.70– 36.60. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.

In addition, bioMérieux offers a competitive Total Rewards package that may include:

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves