Quality Engineer II

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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