LanceSoft, Inc. ยท 2 days ago
Quality Assurance Tech 2
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Information Technology
Insider Connection @LanceSoft, Inc.
Responsibilities
Independently perform and document final inspection of all production slides, vials, kits, and labels to established quality specifications, and make independent determination of acceptability for release.
Independently perform incoming inspection of a wide variety of materials, analyze inspection results versus specifications, ensure correct sampling plans are used.
Work with production associates to ensure materials utilized are released and correctly accounted for, line verification is performed prior to start of production, verify accuracy and completeness of documentation, and confirm equipment used meets designated specifications including calibration.
Work with manufacturing personnel to accurately complete required Quality Control (QC) testing, documentation and determine correct disposition.
Detect nonconforming conditions during inspection and accurately document each condition. Demonstrate a bias for action to determine scope of nonconforming conditions, and segregate nonconforming products to prevent further use.
Perform basic lab support functions, including preparation of basic standards and reagents, PM, 5S, and cleaning and handling of hazardous waste as appropriate.
Responsible for maintenance of retention samples, and electronic and physical storage of device history records.
Must perform work in a safe manner adhering to gowning and PPE procedures.
Participation in continuous improvement activities is required (e.g. kaizen).
Additional responsibilities as assigned by management
Qualification
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Required
High School Diploma/GED with a minimum of 2 years related QC or manufacturing experience
Basic knowledge of SAP is preferred
Experience working in an FDA regulated environment is highly desirable
General Proficiency in Microsoft Office
Demonstrated understanding of sampling techniques and inspection standards
Basic math skills and the ability to utilize Excel for basic calculations and graphing
Must be able to speak, read, and write English fluently as well as write technically and summarize information into data reports using Microsoft Word
Excellent attention to detail with a high degree of accuracy and the ability to work independently and in team situations
Excellent observation skills with a bias for 'corrective action' and improve work environment processes and procedures
Demonstrated ability to make critical decisions regarding product quality or quality system compliance
Ability to assess and articulate risk when evaluating a situation
Knowledge of basic validation, equipment calibration, and change requirements
Demonstrated understanding of the use of calibrated equipment
Proven capability to prioritize responsibilities and complete tasks on schedule
Must be able to work independently in a fast-paced manufacturing environment
Ability to stand for long periods of time
Ability to lift 25 lbs
Ability to do repetitive motion
Preferred
Basic knowledge of SAP is preferred
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization, and a pioneer in providing premium end-to-end Global Workforce Solutions and IT Services to diverse clients across various domains.
H1B Sponsorship
LanceSoft, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (20)
2022 (22)
2021 (46)
2020 (69)
Funding
Current Stage
Late StageCompany data provided by crunchbase