US Tech Solutions · 9 hours ago
QC Lab Operations (Data Integrity Specialist III)
Cincinnati, OH
Contract
Onsite
Mid, Senior Level
$30/hr - $33/hr
4+ years expUS Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. The Senior Specialist, Lab Services is responsible for planning, coordinating, and implementing initiatives that provide quality assurance support for QC Lab Operations, ensuring compliance with corporate and governmental regulations.
Information Technology
Hiring Manager
Shivangi Shivpuri
Responsibilities
Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed
Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed
Serve as calibration coordinator for lab including approval and scheduling of service requests, impact assessment of demand maintenance on instrument qualification status, assignment, review, and approval of instrument related investigations, and creation of workorders in Maximo to capture vendor visits/maintenance as well as adding new instruments and decommissioning old instruments as needed
Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures
Perform assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps
Mitigate and implement improvements within the quality system
Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests
Participate on validation review board as area validation for equipment qualifications
Assist in the design of effective quality systems, procedures, and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system
May be asked to assist in development, revision, or implementation (including delivering training) of training modules, videos, and documents to the local and to global labs
Qualification
Required
GMP Lab Experience of 6+ years
Documentation Review
Empower
LIMS
Electronic Lab Notebook (ELNs)
4+ years' experience in quality assurance, quality oversight or relevant experience
Preferred
Knowledge and familiarity with product testing, test method requirements, and capabilities of common lab instrumentation
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products
Experience leading teams to deliver tactical results
Communication and interpersonal skills
Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
Company
US Tech Solutions
US Tech Solutions counted among the largest yet the fastest growing staffing firm; all achieved organically.
1001-5000 employees
H1B Sponsorship
US Tech Solutions 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 (4)
2024 (9)
2023 (13)
2022 (24)
2021 (18)
2020 (14)
Funding
Current Stage
Late StageLeadership Team
Manoj Agarwal
Chief Executive Officer
Recent News
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2024-12-13
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