Lead, Quality

3 weeks ago

North Charleston, United States Cole-parmer Instrument Company Full time
Job Description Job Description Job Title: Lead, QualityReports To: Quality ManagerPosition Location: North Charleston, SCFLSA Status (Exempt/Non-Exempt): ExemptPosition Summary:The Quality Lead is an intermediate position within the High Purity Standards (HPS) division of Antylia Scientific. This role ensures HPS is operational on a daily basis to meet company objectives as well as ensure compliance with ISO 17025, ISO 17034 and ISO 9001 compliance.Key Responsibilities:Initiate, review, and revise company SOPs, QC records, and other compliance documentation as needed.Participate in design control and risk management activities as needed.Perform equipment validation as needed.Compose audit responses to Internal Quality Audits with corrective actions and perform actions necessary for compliance and audit closure.Review and approve quality data and file as necessary, report non-conformances, forward completed quality records to QA, and maintain data trending databases and records.Maintain and systematically review relevant department SOPs and coordinate revisions when required.Maintain QA program in state of inspection readiness.Performs other duties as assigned.Review Quality systems for compliance with ISO regulationsReview and update Quality Assurance Manual as neededReview current standards and policies suggest improvementsStandardize product development protocol document product scopecreate project/task checklisttrack project statusdocument lessons learnedReview and organize all calibration records (hoods, balances, pipettes and weights)Suggest quality improvements to management staffAssure the reliability and consistency of production by checking processes and final outputReview/update customer feedback forms to include metricsInvestigate customer complaints and non-conformance issuesAssure ongoing compliance with quality and industry regulatory requirementsEducation:Bachelors Degree in life sciences related field requiredExperience:3-5 years experience in a Quality related field, preferably in a chemical manufacturing environment.Minimum Requirements/Qualifications:Excellent technical writing, communication, and organizational skills.Attention to detail.Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraintsExcellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organizationStrong work ethic and an ability to excel within a rapidly changing and growing organizationThorough knowledge of methodologies of quality assurance and standardsExcellent numerical skills and understanding of data analysis/statistical methodsWorking knowledge of ISO regulations (ISO 9001, ISO 17025 & ISO 17034)This position has not been approved for Relocation Assistance.The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.#J-18808-Ljbffr

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