Quality Assurance Engineering Specialist

Quality Assurance Engineering Specialist

Gaithersburg, MD

Your Tasks:
The QA Engineering Specialist is primarily responsible for providing quality involvement and oversight during product development and manufacturing, particularly related to the design and qualification of new equipment. Observe critical operations and procedures as they occur, audits documentation, records activities and keeps management informed on quality issues.  This role also leads continuous improvement objectives to assure compliance with government regulations and advises senior management on findings and recommendations related to Quality, Facilities, Engineering and Validation issues.

Requirements:
• Bachelor’s in the life sciences from a four year college or university; or equivalent combination of education and experience
• At least 3-5 years cGMP experience, with at least 2 years in an engineering, validation or quality assurance role; or a combination of equivalent education and experience
• Must be authorized to work in the U.S.

COMPUTER SKILLS:
To perform this job successfully, an individual should have knowledge of MS Office (incl. Access, Excel, Word, etc.), JMP statistical software, Master Control, PowerPoint and Visio knowledge a plus.

PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.  Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. 

WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

Lentigen, Inc. is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

To apply, please go to: https://recruiting.ultipro.com/MIL1021/JobBoard/f8aa5bf4-ab27-596f-9a7d-4ed2197b270d/Opportunity/OpportunityDetail?opportunityId=61203c6b-13ee-4300-9a85-bd257647e741