Job Description
Job Title: Specialist, QA Engineering
Job ID: 24-03763
Location: Warren NJ, 07059
Duration: 12 Months contract on W2
Onsite role, Warren NJ
Work Schedule: Monday - Friday, Business Hours
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.
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.
- Experience in 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 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, 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.
- Drive strong collaboration within the site and across the network.
EDUCATION AND EXPERIENCE (As Applicable)
- B.S. degree required.
- 1 - 3 years of experience in the pharmaceutical or related industry.
- Equivalent combination of education and experience acceptable.
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.
ADDITIONAL INFORMATION: - Contingent Workers whose jobs involve the operation of a vehicle or machinery, or physical presence in a 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.
- Suppliers and the Contingent Worker are responsible for insuring they are fit for all the duties of the job.
Job Tags
Contract work, Monday to Friday,