What are the responsibilities and job description for the QA Engineer position at Axelon Services Corporation?
Job Description : Specialist, QA Engineering
Onsite role, Warren NJ
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, review of 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 knowledge and experience with GMP, Quality and compliance.
- Previous experience as a computer system validation / quality assurance for life sciences company regulated by
the FDA is preferred.
equipment / facility qualification documentation.
Mountain RAM) and quality systems software (e.g. Veeva).
technical areas.
consistent with Quality risk management principles.
productivity within the group or project.
3. DUTIES AND RESPONSIBILITIES
documents for all equipment and facility activities; investigations and evaluation of change control.
safety and quality of Client's products.
change, release and deviations.
design.
ssociated reports and procedures.
thorough impact assessment, root cause analysis and corrective / preventive actions are documented and
implemented.
transfers supporting the Qualification and Validation teams.
requirements.
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 intended to describe those functions that 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. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
6. ADDITIONAL INFORMATION :
laboratory, research, drug development, or manufacturing facility are prohibited from having any amount of alcohol
or illicit drugs in their body while in the workplace or performing their job functions.
