Analytical Sciences Quality Lead jobs in United States
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Talent Groups ยท 13 hours ago

Analytical Sciences Quality Lead

positionNew Haven, CT
timeContract
remoteOnsite
senioritySenior Level, Lead/Staff
date8+ years exp

Talent Groups is seeking an Analytical Sciences Quality Lead to provide quality partnership and oversight for Product Development Clinical Supply activities at the New Haven site. This role involves ensuring compliant execution of analytical testing and method validation across clinical programs.

IT Management
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H1B Sponsor Likelynote
Hiring Manager
Venkatesh Ergadindla
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Responsibilities

Provide quality oversight for analytical method validation, transfers, and assay qualification for clinical products
Review and approve analytical, stability, equipment qualification, and verification reports
Perform data verification for CMC sections supporting regulatory filings
Partner with PDCS Compliance and ADQC teams to manage QMS records (Deviations, Change Controls, CAPAs, LIRs)

Qualification

CGMP Quality AssuranceAnalytical method validationTechnical transfersBiological SciencesChemical SciencesPharmaceutical SciencesData verificationQuality Management System (QMS)

Required

8+ years of c GMP Quality Assurance experience in biotech or pharmaceutical environments
Strong background in analytical sciences with hands-on method validation and transfer experience
Provide quality oversight for analytical method validation, transfers, and assay qualification for clinical products
Review and approve analytical, stability, equipment qualification, and verification reports
Perform data verification for CMC sections supporting regulatory filings
Partner with PDCS Compliance and ADQC teams to manage QMS records (Deviations, Change Controls, CAPAs, LIRs)
BSc or MS in Biological, Chemical, or Pharmaceutical Sciences (or equivalent industry experience)

Company

Talent Groups

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Talent Groups delivers exceptional experiences by solving the toughest IT talent and technology challenges across all industries.
dateFounded in 2018
location
Houston, Texas, USA
people-size501-1000 employees
web-link
https://talentgroups.com/

H1B Sponsorship

Talent Groups 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
2023 (1)

Funding

Current Stage
Late Stage
Total Funding
unknown
2018-07-01Acquired

Leadership Team

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Matthew James Ripaldi
Chief Executive Officer
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