Katalyst CRO · 1 month ago
Quality Control Associate
Brooklyn Park, MN
Contract
Onsite
New Grad, Entry LevelKatalyst CRO is a contract research organization focused on providing quality control services. They are seeking a Quality Control Associate to independently execute and review various testing methods, maintain laboratory operations, and ensure compliance with quality standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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