SalaryUSD BASED ON EXPERIENCE BASED ON EXPERIENCE
SourceAlpha Consulting Corp.
QUALITY ASSURANCE ASSOCIATE WITH PHARMACEUTICALBOTHELL, WA Project Description: The Quality Associate I position plays a key role in supporting the cGMP quality operations for the Bothell Manufacturing Plant (JuMP). Primary Responsibilities include the review of cGMP batch records, product receipt and packaging. This role directly supports JuMP's release for infusion (RFI) timeline from the date of manufacture and will support all activities for routine clinical and commercial product release at JuMP with an emphasis on supporting Manufacturing with a Quality perspective within a regulated cGMP environment.
- Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
- Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Oversee manufacturing operations during patient material receipt and drug product pack out.
- Support the release of routine preventive maintenance and calibration of equipment.
- Bachelor's degree in relevant science or engineering discipline is preferred.
- Minimum of Associates degree and/or equivalent combination of education and experience is required.
- 0-2 years of relevant cGMP experience.
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
- Hands-on experience with batch record review and product disposition is preferred.
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Detail oriented team player with effective planning, organization and execution skills.
- Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
- Good organization and time management skills.
- Ability to work in a high paced team environment.
- Strong written and verbal skills.
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
- Work in areas that may have strong magnets.
- May work in areas with exposure to vapor phase liquid nitrogen.
- Must be able to obtain gowning qualification to enter a cleanroom environment.
- May be required to work nights, weekends and holidays in a 10-hour shift structure.
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.