Quality Assurance Associate II (Temp to Hire)

Tandem Diabetes Care•San Diego, CA

10d•$23 - $24•Onsite

About The Position

Quality Assurance Associates at Tandem perform inspection and release of manufacturing goods during the manufacturing process by conducting routine and non-routine verification and review of in-process and finished products under general supervision and according to Quality Test Procedures (QTP) & Standard Operation Procedures (SOPs). Compiles data for documentation of test procedures and may assist with report preparation. A Quality Assurance Associate at performs In-process, Final Inspection and Final Approval of Product.

Requirements

Associate’s degree or combination of education and applicable job experience.
5 plus years’ relevant quality and/or manufacturing experience in a FDA regulated industry, preferably medical devices
Experience with QSRs, QC testing methods and general knowledge of GMP requirements for production.
Experience with lot release, document review, and in-process inspection.
Deep understanding of GMP regulations and Process Controls, including document review, in-process and final acceptance criteria, identification and traceability requirements, and segregation of materials.
Able to effectively share information and ideas within and outside of department in written or verbal form; able to put forth own ideas and gain understanding from others.
Proficient at supporting effective interactions between team members and among cross-functional teams.
Demonstrated ability to schedule and coordinate project priorities and resources and to produce high quality work.
Proficient experience with MS Office suite (Word, Excel, Outlook).
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

Bachelor’s degree preferred.

Responsibilities

Reviews and approves manufacturing Design History Records (DHRs), associated test reports and records and reports abnormalities.
Verifies training and other records for compliance to specifications.
Assists with resolving non-conformances occurring with in-process and finished products.
Provides quality oversight of manufacturing process/final packaging.
Updates departmental spreadsheets and statistics.
Assists in revising DHR’s, work instructions, SOP’s, process risk documents, etc.
Maintains department documentation and inventory of retained materials.
Reviews and approves manufacturing records such as test reports and 5S log-sheets.
Checks PM logbooks on manufacturing equipment for completeness and accuracy.
Verifies area equipment is within calibration specifications.
May assist with Incoming Inspections as required.
Assists with Internal audits and participates in 3rd party audits.
Confirms completion of required training plan before assuming job responsibilities.