Job ID:
J37446
Job Title:
CSV Quality Analyst
Location:
Rtp, NC
Duration:
12 Months + Extension
Hourly Rate:
Depending on Experience (DOE)
Work Authorization:
US Citizen, Green Card, OPT-EAD, CPT, H-1B,
H4-EAD, L2-EAD, GC-EAD
Client:
To Be Discussed Later
Employment Type:
W-2, 1099, C2C
As part of the IT Quality team, deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external. The Quality Associate III is expected to have working-level knowledge of CS validation, including the quality systems supporting it (i.e., change management, exceptions management, risk management). Foundational and executable regulatory expectations for CS. Works with peers locally to ensure practices are consistent with requirements and expectations set forth within the governing QMS.
Support the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns to industry as well as client expectations through the review and approval of life cycle deliverables.
Under the guidance of management, perform supporting quality related activities associated with computerized systems including periodic reviews, change management, risk management, etc. for assigned systems in alignment with noted KPIs.
Under the guidance of management, provide quality assurance oversight for system related issues (deviations, incidents, etc.)
Perform all assigned and required trainings to maintain 100% compliance.
Bachelor Degree (BS) from a four (4) year college or university with as emphasis in Engineering, Life Sciences or IT related discipline with relevant experience. Advanced degree preferred.
5+ years related experience and/or training with a least 2 years in a CSV/Quality role. Background in Lifesciences and/or Pharma/Biotech Industries:
MACHINE LEARNING TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. MACHINE LEARNING TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will MACHINE LEARNING TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract