Quality Engineer II — Computer System Validation

BioAgilytix Labs, LLC; Durham (NC); Ibrido; USD 85.000 - 110.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical Insurance

401k Match

Paid Time Off

Parental Leave

Paid Holidays

Dental Insurance

Vision Insurance

Flexible Spending Account

Descrizione del lavoro

BioAgilytix Labs, LLC is seeking a Quality Engineer II to provide QA oversight of computer system validations and equipment qualifications in a fast-paced biotech environment.

The role requires collaboration with multiple teams to ensure GxP compliance, review validation docs, and manage QA processes across systems and equipment. A bachelor’s degree and 5+ years in regulated pharma are required.

Competenze

• 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).

Mansioni

• Provides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)
• Ensures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs
• 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
• Other duties as needed

Conoscenze

GxP regulations

QA oversight

CS validation

Documentation

Vendor qualification

Regulatory inspections

Project management

Formazione

Bachelor's degree

Strumenti

LIMS

ELN

QCBD

ZenQMS

Blue Mountain

Descrizione del lavoro

At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

The Quality Engineer II is responsible for providing quality assurance (QA) oversight of computer validations and equipment qualifications. He or she is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success and meets business needs.

Essential Responsibilities

• Provides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)
• Ensures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs
• 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

Additional Responsibilities

• Other duties as needed

Minimum Preferred Qualifications - Education/Experience

• 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)

Minimum Preferred Qualifications - Skills

• Project management skills not required but preferred.
• Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
• Ability to provide QA oversight for the implementation, maintenance, and enhancement of a LIMS system, ensuring the system remains in a validated state throughout its lifecycle.
• Ability to apply validation engineering principles to the design and implementation of projects
• Knowledge of IT infrastructure and information database systems
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
• Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
• Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
• Excellent written and verbal communication skills
• Versatility, flexibility, and willingness to work within constantly changing priorities
• Ability to deal effectively with a diversity of individuals at all organizational levels

Supervisory Responsibility

• This position has no supervisory responsibility

Supervision Received

• Infrequent supervision and instructions
• Frequently exercises discretionary authority

Working Environment

• Primarily office
• Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets

Position Type and Expected Hours of Work

• This is a full-time position
• Some flexibility in hours is allowed, by the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
• Occasional weekend, holiday, and evening work required

BENEFITS AND OTHER PERKS

Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), 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

COMMITMENT TO EQUAL OPPORTUNITY

BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

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