QMS Specialist 1 at bioMerieux Inc.

Description 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 DutiesPerform Quality review of lot batch records for good documentation requirements and paperwork meets process specifications for product releaseCoordinate Change Request workflows and publish controlled documents within Document Control system, LLDC. Performs initial review of all Corporate driven procedure changes and manages Corporate Document Change Impact process Oversee the learning management system. Log completed training, generate reports and optimize training requirements for managementSupports site continuous improvement activitiesSupports activities related to Quality Events and CAPA activitiesCoordinates internal and external audit schedule with stakeholdersProvides input for improvement in the Quality Management SystemSupport Quality Engineers with determination of Key Performance IndicatorsPerform all work in compliance with company quality procedures and standardsPerforms other duties as assignedMinimum Qualifications:High School Diploma, GED or equivalent required4 years of experience in quality managementBackground with implementation of process improvement programsCcomputer skills including Microsoft Office SuiteKnowledge of ISO 9001 preferred.Knowledge, Skills and Abilities:Detail orientation to complete tasks without errors and produce high-qualityCritical thinking, using logic and reason to analyze information and make decisions in the workplaceProblem solving to find solutions to complex business challengesStrong interpersonal skills and great attention to detail are necessaryAbility to manage indirect relationships and project successfullyElevate issues to management, when appropriateMust be able to handle multiple projects concurrentlyPhysical requirements: Ability to remain in stationary position, often standing, for prolonged periodsAbility to ascend/descend stairs, ladders, ramps, and the likeAbilityto wear PPE correctly most of the day.Ability tooperate heavy machineryAbility to adjust or move objects up to 50 pounds in all directionsDomestic travel - 10%The estimated hourly wage range for this role based in Illinois is between $26.00 - 36.50. 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, bioMerieux 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#LI-US Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMerieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [emailprotected]. BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).