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Senior Quality Control Analyst jobs in United States
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TalentBurst, an Inc 5000 company · 1 day ago

Senior Quality Control Analyst

TalentBurst, an Inc 5000 company, is seeking a Senior Quality Control Analyst to support production through technical transfer activities and quality testing. The role involves applying job skills, running test samples, reviewing assays, and ensuring compliance with quality systems and data integrity principles.
RecruitingStaffing Agency
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Sudarshan Mishra
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Responsibilities

Applies job skills and company's policies and procedures to complete a variety of tasks
Running test samples for In-Process, Lot Release and Stability studies
Running test samples for (but not limited to) investigations, transfers and validations
Reviewing assays
Training others
Has experience with: Change Control, Deviations, CAPAs, Tasks, EICRs, Investigations
Writing – Quality Records (Deviations, CAPA, Change Control) and Test Methods
Projects – such as method transfers, new instruments, method qualifications
Use of Microsoft Suites (Word, Excel, PowerPoint)
Use of Laboratory computer systems
Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required
Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
Apply Data Integrity principles in all aspects of work, in compliance with client policies, guidelines and procedures
Perform other duties as assigned
Has experience with or currently uses the following software: SoftMaxPro, Empower, SoloVPE
Has experience with software validations including but not limited to: Writing GMP procedures and validation documents
Executing test scripts
Acts as a SME for at least one software system
Communicates with cross functional teams to interpret needs and priorities
Can perform technical, root-cause analysis for some software errors

Qualification

Quality ControlGMP Quality SystemsSoftMaxProEmpowerLaboratory computer systemsTechnical TransferData IntegrityMicrobiologyBiochemistryRoot-cause analysisTraining othersWriting Quality RecordsCross-functional communication

Required

Experience with Change Control, Deviations, CAPAs, Tasks, EICRs, Investigations
Writing Quality Records (Deviations, CAPA, Change Control) and Test Methods
Projects such as method transfers, new instruments, method qualifications
Use of Microsoft Suites (Word, Excel, PowerPoint)
Use of Laboratory computer systems
Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
Ability to recognize deviation from accepted practice
Ability to analyze situations or data requiring a review of identifiable factors
Apply Data Integrity principles in all aspects of work, in compliance with client policies, guidelines and procedures
Experience with SoftMaxPro
Experience with Empower
Experience with SoloVPE
Experience with software validations including writing GMP procedures and validation documents
Executing test scripts
Acts as a SME for at least one software system
Communicates with cross functional teams to interpret needs and priorities
Can perform technical, root-cause analysis for some software errors
Associate's Degree in Microbiology, Biochemistry or Related Science Fields

Company

TalentBurst, an Inc 5000 company

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Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.

H1B Sponsorship

TalentBurst, an Inc 5000 company 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 (3)
2023 (7)
2021 (1)
2020 (4)

Funding

Current Stage
Late Stage

Leadership Team

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Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
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Company data provided by crunchbase