Katalyst CRO · 1 month ago
Quality Control Analyst- LABORATORY
Brooklyn Park, MN
Full-time
Onsite
Mid Level
3+ years expKatalyst CRO is a confidential company seeking a Quality Control Analyst for their laboratory operations. The role involves executing and reviewing test methods, maintaining lab operations, and ensuring compliance with quality standards and regulations.
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
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
Testing Method(s) experience
Good communication skills
Experience with a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, MODA)
A Good understanding of laboratory operations and Standard Operating Procedures (SOP's)
Experience authoring new SOP's and initiate changes to existing procedures
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
Preferred
Previous experience in a regulated environment preferred
3-6 years of relevant experience preferred
QC Micro Skill Set – Contamination control, Endotoxin, Bioburden, Environmental Monitoring, Manufacturing Cleanrooms, Aseptic Technique, Critical Utility systems
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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