Sr. QA Engineering Specialist (Onsite, Warren, NJ)

Sr. QA Engineering Specialist (Onsite, Warren, NJ)

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.

Responsibilities :

Functional responsibilities include ensuring accurate and timely maintenance of validation and qualification documents for all equipment and facility activities;

investigations and evaluation of change control.

• Ensure IT systems are designed, set, and function in a GMP-compliant manner to safeguard and maintain the safety and quality of products.
• Provides QA oversight on key software development life cycle (SDLC) processes such as problem, incident, change, release, and deviations.
• Support the qualification and validation activities related to QC, manufacturing equipment, and facility design.
• Assures appropriateness of calibration / maintenance programs, validation plans, qualification protocols, associated reports, and procedures.
• Support ECQ, Facilities, QC, and manufacturing equipment-related investigations in ensuring appropriate and thorough impact assessment, root cause analysis, and corrective / preventive actions are documented and implemented.
• Ensures compliance with the site validation master plan, assists with facility start-up operations and product transfers supporting the Qualification and Validation teams.
• Work with Engineering / Facilities / ECQ management to ensure functional activities comply with global regulatory requirements.
• Sponsor and support the change initiatives and the implementation of process improvement initiatives.
• Ensure the site is compliant with global and regulatory data governance and data integrity requirements.
• Manage development of technical or scientific initiatives and activities by interdisciplinary teams.
• Critically review investigations and reports, interpret results, and generate technical conclusions

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 https : / / www.stage4solutions.com / careers / (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.