Quality Control jobs in United States
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ACL Digital ยท 1 day ago

Quality Control

ACL Digital is seeking a Quality Control professional to ensure the integrity of products through rigorous testing and compliance with GMP standards. The role involves performing analytical testing, maintaining laboratory instruments, and supporting product release processes.

Business IntelligenceCloud ComputingDevOpsHardwareInformation TechnologyInternet of ThingsMobile AppsRetail TechnologySaaSSoftware
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H1B Sponsor Likelynote
Hiring Manager
Lakshmi Shetty
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Responsibilities

Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays
Work with internal and external resources to maintain lab in an optimal state
Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release
Maintains laboratory instruments for calibration and routine maintenance
Author or revise SOPs, qualification/validation protocols and reports
Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures
Provide updates at daily and weekly meetings
Monitor the GMP systems currently in place to ensure compliance with documented policies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
Gather metric information for use in continuous improvement of areas of responsibility
Perform other duties as required

Qualification

Flow CytometryELISAQPCR assaysCell based bioassaysSOP authoringGMP complianceData monitoringRoot cause analysis

Required

Shift flexibility preferred
For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training
Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays
Work with internal and external resources to maintain lab in an optimal state
Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
Supply information to support generation of CoAs for product release
Maintains laboratory instruments for calibration and routine maintenance
Author or revise SOPs, qualification/validation protocols and reports
Assist with lab investigations regarding out of specifications (OOS) results
Participate in determination of root cause for deviations related to analytical procedures
Provide updates at daily and weekly meetings
Monitor the GMP systems currently in place to ensure compliance with documented policies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
Gather metric information for use in continuous improvement of areas of responsibility
Perform other duties as required

Company

ACL Digital

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ACL Digital is a design-led digital engineering and transformation firm.

H1B Sponsorship

ACL Digital 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 (38)
2024 (29)
2023 (26)
2022 (33)
2021 (20)
2020 (19)

Funding

Current Stage
Late Stage

Leadership Team

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Srikanth Raghavan
Associate Vice President
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Company data provided by crunchbase