Katalyst CRO
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Validation / Quality Assurance Analyst.
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Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Validation / Quality Assurance Analyst.
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.). Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems. Author validation life cycle documents for client's review and approval. Route drafted documents for review. Route reviewed documents for workflow approval. Request approval workflows to Doc Control. Execute approved protocols in GxP facility. Understand SDLC process and SDLC methodology such as agile etc. Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables. Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area. Author change control documents for client review and approval.
Responsibilities
Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.). Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems. Author validation life cycle documents for client's review and approval. Route drafted documents for review. Route reviewed documents for workflow approval. Request approval workflows to Doc Control. Execute approved protocols in GxP facility. Understand SDLC process and SDLC methodology such as agile etc. Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables. Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area. Author change control documents for client review and approval.
Requirements:
Prior experience with benchtop instrument experience is a must. Bachelor's/ master's degree or equivalent in a scientific or health care field. 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred. Prior experience with benchtop instrument experience is a must. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Quality Assurance Analyst” roles.
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Validation / Quality Assurance Analyst.
role at
Katalyst CRO 3 days ago Be among the first 25 applicants Join to apply for the
Validation / Quality Assurance Analyst.
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.). Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems. Author validation life cycle documents for client's review and approval. Route drafted documents for review. Route reviewed documents for workflow approval. Request approval workflows to Doc Control. Execute approved protocols in GxP facility. Understand SDLC process and SDLC methodology such as agile etc. Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables. Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area. Author change control documents for client review and approval.
Responsibilities
Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems. Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.). Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems. Author validation life cycle documents for client's review and approval. Route drafted documents for review. Route reviewed documents for workflow approval. Request approval workflows to Doc Control. Execute approved protocols in GxP facility. Understand SDLC process and SDLC methodology such as agile etc. Work with different stakeholders (IT, Network, Vendor) team in delivering validation project deliverables. Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area. Author change control documents for client review and approval.
Requirements:
Prior experience with benchtop instrument experience is a must. Bachelor's/ master's degree or equivalent in a scientific or health care field. 7+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred. Prior experience with benchtop instrument experience is a must. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for “Quality Assurance Analyst” roles.
Rensselaer, NY $80,000.00-$95,000.00 2 weeks ago Albany, NY $100,000.00-$140,000.00 1 month ago Albany, NY $80,000.00-$120,000.00 1 month ago Albany, NY $100,000.00-$140,000.00 1 month ago Menands, NY $62,962.00-$74,750.00 2 weeks ago QA Specialist (Drug Product) - 3rd Shift
Albany, NY $50,400.00-$55,459.00 4 days ago Menands, NY $86,681.00-$109,650.00 2 days ago Albany, NY $90,000.00-$130,000.00 1 month ago Schenectady, NY $68,800.00-$79,120.00 1 month ago Rensselaer, NY $84,000.00-$105,000.00 2 days ago QA Specialist (Drug Product) - 3rd Shift
Albany, NY $100,000.00-$140,000.00 1 month ago Senior Consultant - Healthcare Quality Assurance (QA) Tester
Albany, NY $79,000.00-$109,000.00 1 week ago Albany, New York Metropolitan Area 3 days ago Composition Quality Assurance Administrator, Temporary
Discovery Business and System Analyst (Top Secret Clearance Required)
Albany, NY $92,543.50-$125,594.75 1 week ago Albany, NY $60,000.00-$110,000.00 1 month ago Business Systems Analyst 1, SG-18, Business Systems Analyst TR 2, SG-16, Business Systems Analyst TR 1, SG-14(NYHELPS) Item# 00286
Albany, NY $53,764.00-$85,138.00 1 week ago Enterprise Resources Planning Business Analyst
Embedded Banking IT Senior Business Analyst
Albany, NY $95,000.00-$105,000.00 3 weeks ago East Greenbush, NY $55,000.00-$105,000.00 1 hour ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr