Quality Control Analyst II jobs in United States
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LanceSoft, Inc. · 1 day ago

Quality Control Analyst II

LanceSoft, Inc. is a company seeking a Quality Control Analyst II to ensure compliance with quality control standards in a laboratory environment. The role involves executing routine testing, maintaining laboratory operations, and authoring quality system events while adhering to cGMP regulations.

Information Technology
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner
Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, MODA)
Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal)
Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability
Own and author quality system events (i.e., laboratory investigations, deviations, CAPA’s and change controls)
Demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures (SOP’s)
Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required
Complete all testing, including special project and protocol testing in a timely and appropriate manner
Maintain data integrity and ensure compliance with company SOP’s, specifications, and cGMP regulations
Independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions
Decisions have moderate impact on future QC processes and procedures that impact batch disposition
Participate in cross-functional teams
Author new SOP’s and initiate changes to existing procedures
May be required to work overtime or be assigned to a different shift as needed
Perform equipment maintenance and calibrations as required
Complete mandatory training within required timeframe
Perform other duties as assigned

Qualification

Laboratory instrumentationCGMP knowledgeQC Micro Skill SetLife Sciences degreeRegulated environment experienceBasic computer skillsEagerness to learnEffective communicationInterpersonal skills

Required

Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework
3-6 years of relevant experience preferred
Must understand laboratory instrumentation
Must be able to communicate effectively with managers and peers
Must be able to read, write, and converse in English
Must have basic computer skills. General use of word processing, spreadsheets, databases, etc. for the purposes of work execution, training, performance management, and self-service
Good interpersonal skills and able to work effectively and efficiently in a team environment
Knowledge of cGMP manufacturing
Knowledge of chemical, biological and/or microbiological safety procedures
Must display eagerness to learn and continuously improve

Preferred

3-6 years of relevant experience preferred
Previous experience in a regulated environment preferred

Company

LanceSoft, Inc.

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Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.

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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (32)
2023 (23)
2022 (25)
2021 (60)
2020 (80)

Funding

Current Stage
Late Stage

Leadership Team

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Ram Karuppusamy
Chairman & CEO
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Simon Dealy
Chief Financial Officer
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Company data provided by crunchbase