- 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, OECD 17, CLIA and GAMPs
- Performs the quality review of equipment SOPs, policies, and the computer validation and equipment qualification master plan, as required
- Responsible for Quality 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, equipment software, etc.)
- Responsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing
- Assists with the periodic reviews of validated systems and confirms all required follow-up actions are completed
- Responsible for writing, reviewing and approval of validation documentation for new and existing computer systems/equipment subject to validation
- Serves as Quality Engineer representative during regulatory agency and sponsor inspections
- Assists with the review and approval of change controls and Out of Tolerance investigations
- Perform duties with minimal Quality Engineer Management oversite
- Other duties as needed
- Bachelor's degree in biology, 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)
- Project management skills not required, but preferred
- Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
- 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 n 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
- This position has no supervisory responsibilities
- Infrequent supervision and instructions
- Frequently exercises discretionary authority
- Primarily office
- Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
- Ability to work in an upright and/or stationary position for more than 8 hours per day
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate office equipment
- Frequent mobility required
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying (or otherwise moves) objects including files and laptop computer with a maximum lift of 20 pounds
- Ability to access and use a variety of computer software
- Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
- Frequently interacts with others to obtain or relate information to diverse groups
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
- Ability to perform under stress and multi-task
- Regular and consistent attendance
- 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
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Quality Engineer II - Durham, United States - BioAgilytix
Description
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-Validations is responsible for providing 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 ResponsibilitiesEducation/Experience:
Skills:
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 (12 scheduled; 3 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.
Quality Engineer II professionals in Durham
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James DeCarlo
Permanent or contract Validation Engineer.