Sr Qa Engineering Specialist Onsite Warren Apply
We are looking for a Quality Validation Engineer for our client, a Global pharmaceutical Company. This role involves ensuring the quality, integrity, and compliance of site Information Technology (IT) systems, as well as reviewing validation and qualification documents for all equipment and facility activities. The position is part of the Cell Therapy Development and Operations (CTDO) organization, which provides autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
This is a 40-hour per-week, 12-month contract, 100% onsite role in Warren, NJ (The candidate must be able to work onsite 5 days a week).
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
consistent with Quality risk management principles.
Requirements:
- 8+ years of experience in QA Engineering within the pharmaceutical industry, regulated by the FDA
- Advanced level experience in designing user requirement specifications, IQ/OQ/PQ protocols, user acceptance testing, and other equipment/facility qualification documentation
- Advanced knowledge and experience with GMP, Quality, and compliance
- Must be fluent in standard Microsoft Office software; experience in asset management software (e.g. Blue
Mountain RAM) and quality systems software (e.g. Veeva). - The ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles
- Intermediate knowledge of quality systems including CAPA, change control, and document management systems
- Bachelor's degree
Please submit your resume to our network at (please apply to the Sr. QA Engineering Specialist (Onsite, Warren, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $57/hr - $64/hr.
