LanceSoft, Inc. · 5 days ago
Quality Control Analyst II
Brooklyn Park, MN
Full-time
Onsite
Mid Level
$32/hr - $34.18/hr
3+ years expLanceSoft, Inc. is seeking a Quality Control Analyst II to execute and review laboratory test methods and maintain lab operations. The role involves ensuring compliance with quality standards and participating in cross-functional teams.
Information Technology
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
Required
Bachelor's or master's degree in any Life Sciences with relevant laboratory coursework
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
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
Employee at this level is involved in routine tasks of moderate scope and complexity
Employee receives instructions on new work and refers to policies and procedures for guidance
Responsible for conducting independent work with minimal guidance from trainers and more senior staff
Responsible for contributing to moderate scope decisions founded on sound principles, international industry/regulatory standards, and robust scientific basis
Understand the needs of key collaborators (i.e., Manufacturing Operations, Quality Assurance, Validation and Quality Systems) to provide compliant and timely test results
Participate in cross-functional collaboration with internal departments (i.e., Quality, Manufacturing, Engineering, Metrology, and Business Excellence)
Stand or sit -? Must be able to remain in a stationary or standing position for extended periods of time in both office and laboratory environment
Frequently moves laboratory materials and portable instruments weighing up to 30 pounds
Occasionally ascends/descends step ladders to reach materials and/or stairs to collect samples
Required to gown for cleanroom work, balance and dexterity are required
May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection
May be required to participate in an on-call rotation for off-shift coverage or occasionally work off-shift hours to help support a 24-7 manufacturing department
Willingness to travel to various meetings or training, this could include overnight trips
Requires 0-5% travel
Preferred
3-6 years of relevant experience preferred
Previous experience in a regulated environment preferred
Company
LanceSoft, Inc.
Established in 2000, LanceSoft is a pioneer in delivering top-notch Global Workforce Solutions and IT Services to a diverse clientele.
5001-10000 employees
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 StageLeadership Team
Ram Karuppusamy
Chairman & CEO
Simon Dealy
Chief Financial Officer
Company data provided by crunchbase