CSV Quality Analyst

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

Job summary

An innovative firm seeks a Quality Associate III to join their IT Quality team. This role is crucial for delivering technically robust GxP computerized systems that meet regulatory compliance and withstand audits. You will ensure that the implementation of these systems aligns with industry standards and client expectations. With a focus on quality assurance, you will oversee system-related issues and support the execution of quality-related activities. If you have a background in Life Sciences or Pharma and possess strong knowledge of CS validation and quality management systems, this opportunity could be your next career milestone.

Qualifications

• 5+ years of experience in a CSV/Quality role, preferably in Life Sciences or Pharma.
• Bachelor's degree with emphasis in Engineering or IT is required.

Responsibilities

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

Skills

CS validation

Quality Management Systems (QMS)

Change management

Risk management

GxP compliance

Life Sciences knowledge

Education

Bachelor's 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 Requirements:

1. Bachelor Degree (BS) from a four (4) year college or university with 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.

BLOCKCHAIN 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. BLOCKCHAIN 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 BLOCKCHAIN 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.