CSV Quality Analyst

AI 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'll play a crucial role in ensuring the integrity and compliance of GxP computerized systems. This position requires a solid understanding of computer system validation and quality management systems, making it ideal for someone with a background in life sciences or the pharmaceutical industry. You will collaborate with a dedicated team to support the implementation of compliant systems, ensuring alignment with industry standards and client expectations. If you are passionate about quality assurance and want to make a meaningful impact in a dynamic environment, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in a CSV/Quality role.
• Bachelor's degree required, advanced degree preferred.

Responsibilities

• Deliver compliant GxP computerized systems and ensure audit readiness.
• Provide quality assurance oversight for system-related issues.

Skills

GxP Compliance

Computerized Systems Validation (CSV)

Quality Management Systems (QMS)

Risk Management

Change 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. 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.

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.
3. Background in Lifesciences and/or Pharma/Biotech Industries.

Equal Opportunity Employer
AI 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. AI 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 AI 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.