Quality Control Technician
Mindlance
Quality Assurance SpecialistPerform a wide variety of activities to support the Quality Management System. Essential duties and responsibilities include:Conduct product testing, including testing to support complaint investigations and stability verificationGenerate product testing results reportsReview production batch records for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assure these have been addressed and resolved prior to issuing approvalConduct spot-check inspections/audits of production operationsParticipate in the internal audit programWrite, review and approve Standard Operating Procedures (SOPs) as necessaryMay assist in supporting the Document Control program, record retention areas, and sample retention areasMay support returned instrument processingOther duties as assigned by supervisorThis job has no supervisory responsibilities.Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)Education and/or Experience:Bachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.Language Skills:Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before small groups of customers or employees of organization.Mathematical Skills:Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Computer Skills:To perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.Certificates, Licenses, Registrations - NoneOther Skills and Abilities:Ability to follow procedures and accurately document results Understanding the manufacturing processes of Company products and ability to recognize deviations from approved documented procedures Attention to detail. Ability to use bleach for cleaning purposes is required.Other Qualifications - NonePhysical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is regularly required to sit and stand. The employee is occasionally required to walk.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually quiet.EEO: "Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
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