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 ResponsibilitiesMinimum 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
