This job was posted by https://www.kansasworks.com : For moreinformation, please see: https://www.kansasworks.com/jobs/13100301 WorkLocation: Lenexa, Kansas

Shift: Yes

Department: LS-SC-PMXQA Quality Assurance

Recruiter: Erin Wilson

This information is for internals only. Please do not share outside ofthe organization.

Your Role:

The Quality Assurance Specialist 3, Quality Systems and Product Supportrole is to manage the implementation and maintenance of quality systemsand ensure MilliporeSigma's compliance with government regulations bycoordinating with suppliers and customers to develop consistent andefficient business practices. The Quality Assurance Specialist 3 is thefirst point of contact for managing internal and externalnonconformities. Responsibilities focus on enhancing the Lenexa DryPowder Media manufacturing site by providing expertise in advancedproblem-solving and implementing corrective and preventative actions bycollaborating closely with internal team members, stakeholders,collaborators, and participating facilities.

Review controlled documents to ensure GMP and procedural complianceSupport all product quality-related changes to training curriculums,documents, equipment, specifications, and methods.Investigate nonconformities (Deviations) and manage Corrective andPreventative actionsPreparation of confidential and proprietary documents and agreementServes as an operational resource in the analysis of risk foradverse events through the root cause analysis process usingperformance improvement tools and methodologyDrives expedited problem identification and resolution, provision ofRCA-specific updates, and team interactions and deadlines driven byproduct releaseSite lead user for Quality Management SystemSupport the development of project plans for specific quality systeminitiatives and process improvementsMaintains current understanding of quality systems for businessunits including DPM (Dry Powder Media products) and applies andinterprets regulations in making business decisions and riskassessmentsUtilizes project management tools and methodologies to track andcommunicate the status of RCA and provides regular updates to theRCA Teams, ensuring the team is informed of status updates of theroot cause analysisDemonstrates leadership in developing and implementing qualitysystem initiatives in areas of Operations and Product SupportEstablishes and maintains collaborative relationships within thesystem to foster successful root cause analysis completionLead change team assessment of end-to-end impact for product,process, systems, assay/method, and equipment change controlsDevelops and manages best practices and tools for improvement, planexecution, and project managementEnsure personnel are treated with respect and dignity with anemphasis on providing a strong avenue for communication and companyvaluesWho You Are

Minimum Qualifications:

Bachelor's Degree in Chemistry, Biology, or other Life Sciencediscipline6+ years of experience in Quality Assurance in a GMP environmentOR

Bachelor's Degree in any non-Life Science discipline9+ years of QA experience in a GMP or ISO environment within thepharmaceutical or healthcare industryPreferred Qualifications:

6+ years of experience with quality assurance in Pharmaceutical orBiopharmaceutical with demonstrable familiarity with cGMPs, cGLP'sand/or ISO requirementsThorough understanding of ISO 9001:2015, EXCiPACT, and GMPguidelinesGreen Belt certificationQuality Auditor CertificationHighly refined written and verbal communication skillsAbility to organize tasks effectively with good time management andmulti-tasking capabilitiesAbility to lead multi-functional teams implement projectinitiativesExceptional critical thinking skills with the propensity for makinggood risk-based decisions based upon a mixture of analysis,experience, and judgment promptlyWorking knowledge of computer programs such as TrackWise, SAP, andBPCS, in addition to Microsoft OfficeConsensus builder among teams and cross-functional groups withdiffering objectives and priorities{=html}- Excellent interpersonal skills for interacting with many internal departments and management levels, along with customers, suppliers, and regulatory authorities

RSREMD

The Company is an Equal Employment Opportunity employer. No employee orapplicant for employment will be discriminated against on the basis ofrace, color, religion, age, sex, sexual orientation, national origin,ancestry, disability, military or veteran status, genetic information,gender identity, transgender status, marital status, or any otherclassification protected by applicable federal, state, or local law.This policy of Equal Employment Opportunity applies to all policies andprograms relating to recruitment and hiring, promotion, compensation,benefits,