Quality Engineer II - Computer Systems Validation (GxP)

BioAgilytix Labs, LLC; North Carolina; Presencial; USD 110 000 - 150 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical Insurance (HDHP with HSA; PPO)

Dental Insurance

Vision Insurance

Flexible Spending Account (medical; 35

Short Term Disability

Long Term Disability Life Insurance

Paid Time Off (4 weeks per year)

Parental Leave

Paid Holidays (9 scheduled; 5 floating

401k with Employer Match

Employee Referral Program

Resumo da oferta

BioAgilytix Labs, LLC is seeking a Quality Assurance professional to oversee computer system validation and equipment qualification in a regulated environment. You will guide SOP development, ensure GxP compliance, and coordinate with multiple departments to deliver validated, compliant systems across LIMS, ELN, QCBD, and related software.

Ideal candidates have a strong background in FDA/ICH/GxP regulations, hands-on validation experience, and the ability to manage diverse documentation and

Qualificações

• Bachelor's degree in engineering, information technology, computer science, or related discipline.
• Not less than five (5) years’ experience in pharmaceutical/GxP/regulated environment.
• Direct hands-on experience with computer systems validation and/or equipment qualifications.
• Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO).

Responsabilidades

• Provides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security).
• Performs the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as required.
• Responsible for QA oversight of the computer system validation and equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects (e.g. LIMS, ELN, QCBD, equipment software, etc.).
• Responsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain).
• Responsible for electronic Archives oversight.
• Responsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing.
• Reviews and approves equipment out of tolerances investigations.
• Performs vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activities.
• Confirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow-up actions are completed.
• Responsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validation.
• Reviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as needed.
• Serves as QA representative for the testing of the Business Continuity (e.g. IT testing) and computer system validations and equipment qualification during regulatory agency and sponsor inspections.
• Responsible for QA review and approval of change controls and Out of Tolerances to ensure timely closure.
• Perform duties with minimal QA Engineer Management oversite

Conhecimentos

QA oversight

Regulatory compliance

GxP knowledge

Validation engineering

Documentation

Vendor management

MS Office

Formação académica

Bachelor’s degree in engineering, information technology, computer science, or related discipline

Not less than five (5) years’ experience in pharmaceutical/GxP/regulated environment

Direct hands‑on experience with computer systems validation and/or equipment qualifications

Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)

Ferramentas

GAMP guidelines

LIMS

ELN

QCBD

ZenQMS

Blue Mountain

Descrição da oferta de emprego

BioAgilytix Labs, LLC is seeking a Quality Assurance professional to oversee computer system validation and equipment qualification in a regulated environment. You will guide SOP development, ensure GxP compliance, and coordinate with multiple departments to deliver validated, compliant systems across LIMS, ELN, QCBD, and related software.

Ideal candidates have a strong background in FDA/ICH/GxP regulations, hands-on validation experience, and the ability to manage diverse documentation and