Quality Assurance Specialist - job 2 of 2

Hi Folks, We are looking for Quality Assurance Specialist with-

Strong biologics experience o Strong knowledge of Single use disposable systems o Preferred exp. in manufacturing but quality and/or validation setting exp is acceptable as long as unit ops familiarity exists o Proven experience with authoring, reviewing, approving deviations/non-conformances, SOP, bath records, Specifications) o Trained with understanding of Root Cause Analysis techniques – 5Whys, 6Ms, fishbone, etc. o Have worked with batch records and have familiarity with workings of cGMP manufacturing environment o Life science or engineering degree with at least 5+ yrs of direct relevant experience o Use of TrackWise system or similar operating framework o Strong writing skills is a must o Have worked with CAPA planning, execution of CAPAs and change controls o Strong understanding of quality systems and compliance requirements o Have demonstrated experience in working with batch records and associated process/systems o Detail oriented with strong understanding of data integrity, GDP, and cGMP requirements o Have worked with batch records and have familiarity with workings of cGMP manufacturing environment.

Thanks & Regards,

Shilpi| Sr. Recruiter

shilpi@vastekgroup.com

703-263-8242

Job Type: Full-time

Salary: $27.00 - $33.00 per hour

Benefits:

• Health insurance

Experience level:

• 1 year
• 2 years
• Under 1 year

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Work Location: In person