CSV Quality Analyst

Automation 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 play a crucial role in ensuring that GxP computerized systems are robust and compliant. This position requires a deep understanding of systems validation and quality assurance processes, particularly in the Lifesciences and Pharma/Biotech sectors. You will be responsible for supporting the implementation of computerized systems, conducting quality assurance oversight, and maintaining high compliance standards. If you are passionate about quality and eager to contribute to a team dedicated to excellence in the industry, this opportunity is perfect for you.

Qualifications

• 5+ years of experience in CSV/Quality roles, preferably in Life Sciences or Pharma.
• Bachelor's degree in relevant fields required; advanced degree preferred.

Responsibilities

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

Skills

GxP Computerized Systems Validation

Quality Assurance

Change Management

Risk Management

Life Sciences Knowledge

Pharma/Biotech Industry Knowledge

Education

Bachelor's Degree in Engineering, Life Sciences, or IT

Advanced Degree

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).

Support the compliant implementation of GxP computerized systems (i.e., new, upgrades, changes, etc.) to ensure the approach and execution aligns with 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.

Provide quality assurance oversight for system-related issues (deviations, incidents, etc.) under the guidance of management.

Perform all assigned and required trainings to maintain 100% compliance.

Minimum Qualifications

Bachelor's 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.

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.

AUTOMATION 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. AUTOMATION 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 AUTOMATION 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.