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 GAMPsPerforms the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as requiredResponsible 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 oversightResponsible for the maintenance of the Computer System Validation Status listing and Equipment Master ListingReviews and approves equipment out of tolerances investigationsPerforms vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activitiesConfirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow-up actions are completedResponsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validationReviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as neededServes 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 inspectionsResponsible for QA review and approval of change controls and Out of Tolerances to ensure timely closurePerform 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 disciplineNot less than five (5) years’ experience in pharmaceutical/GxP/regulated environmentDirect hands-on experience with computer systems validation and/or equipment qualificationsDirect hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO) Minimum Preferred Qualifications - Skills Project management skills not required but preferredKnowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principlesAbility to provide QA oversight for the implementation, maintenance, and enhancement of a LIMS system, ensuring the system remains in a validated state throughout its lifecycleAbility to apply validation engineering principles to the design and implementation of projectsKnowledge of IT infrastructure and information database systemsAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policiesAbility to work in fast-paced environment where multiple projects are in process and must be completed in a timely mannerAdvanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)Excellent written and verbal communication skillsVersatility, flexibility, and willingness to work within constantly changing prioritiesAbility 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 instructionsFrequently exercises discretionary authority Working Environment Primarily officeRoutinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets Position Type and Expected Hours of Work This is a full-time positionSome flexibility in hours is allowed, by the employee must be available during the “core” work hours as published in the BioAgilytix Employee HandbookOccasional 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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