What are the responsibilities and job description for the Quality - Specialist, QA Engineering position at Aequor Technologies LLC?
Job Description : Specialist, QA Engineering
100% Onsite Role, Warren NJ
12 Months Contract
Work Schedule : Monday - Friday, Business Hours
1. Purpose and Scope of Position
The Specialist, QA Engineering is responsible for ensuring quality, integrity, and compliance of site Information Technology (IT) systems and reviewing validation and qualification documents for all equipment and facility activities. This position is a member of the Cell Therapy Development and Operations (CTDO) organization, which supplies autologous and allogeneic cell therapies for first-in-human and pivotal clinical trials.
2. Required Competencies : Knowledge, Skills, and Abilities
- Must have advanced knowledge and experience with GMP, Quality, and compliance.
- Previous experience as a computer system validation / quality assurance professional for a life sciences company regulated by the FDA is preferred.
- Advanced level experience in the design of user requirement specifications, IQ / OQ / PQ protocols, user acceptance testing, and other equipment / facility qualification documentation.
- 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).
- Drives use of best practices during IT systems design, validation, and use.
- Must be able to recognize and group technical / scientific attributes and drive science-based decisions in most technical areas.
- Must manage the development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be able 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.
- Requires minimal direction to complete tasks, with the authority to make daily decisions that impact their team.
- Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.
- Consults management for advice on complex issues.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Drives strong collaboration within the site and across the network.
3. Duties and Responsibilities
4. Education and Experience (As Applicable)
5. Working Conditions (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate, and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will perform other job-related duties as requested by management.
6. Additional Information
