CSV Quality Analyst

Ethereum Technologies LLC; North Carolina; On-site; USD 60,000 - 80,000; Full time

Job summary

Join a forward-thinking company as a Quality Associate III, where you will ensure the integrity of GxP computerized systems. This role is pivotal in supporting the implementation and validation of systems that meet rigorous industry standards. You will leverage your expertise in quality assurance and compliance to oversee system-related issues, ensuring that all processes align with both internal and external audit requirements. If you have a strong background in life sciences and a passion for maintaining high-quality standards, this position offers a dynamic environment where your contributions will directly impact the success of critical projects in the pharmaceutical and biotech sectors.

Qualifications

• 5+ years of experience in CSV/Quality roles, preferably in Lifesciences or Pharma/Biotech.
• Strong knowledge of GxP compliance and quality systems.

Responsibilities

• Deliver compliant GxP computerized systems that withstand audits.
• Provide quality assurance oversight for system-related issues.

Skills

GxP Computerized Systems Validation

Quality Assurance

Change Management

Risk Management

Life Sciences Knowledge

Education

Bachelor Degree in Engineering, Life Sciences or IT

Advanced Degree (preferred)

Job description

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.

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.

Minimum Qualifications:

1. Bachelor Degree (BS) from a four (4) year college or university with an emphasis in Engineering, Life Sciences or IT related discipline with relevant experience. Advanced degree preferred.
2. 5+ years related experience and/or training with at least 2 years in a CSV/Quality role. Background in Lifesciences and/or Pharma/Biotech Industries.

Equal Opportunity Employer
ETHEREUM 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. ETHEREUM 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 ETHEREUM 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.