Quality Control, Group Leader of Clinical Products - 2nd Shift - Coyote Technical & Executive Sourcing

Quality Control, Group Leader of Clinical Products - 2nd Shift

Under minimal supervision and following established procedures and guidelines, this position supplies assistance and support to the manufacturing operations (consumables, reagents and instrument areas). The employee will be skilled in the inspection of consumables, testing consumables and/or analytical instrumentation, and fluid manufacturing procedures. The employee will accurately record test data in accordance with established test procedures. The employee will be responsible for overseeing the QC department during 2nd shift. The employee will be trained to electronically transact product through the SAP system. The employee will provide training and troubleshooting guidance for other 2nd shift QC department personnel.

Essential Responsibilities and Accountabilities:

·Perform visual and/or mechanical inspections on completed consumables and reagent department products.

·Perform inspection of documentation revisions. Read and understand APs, TPs, OIs, Ops, drawings, MVs, ECOs, test data and any other documentation in the DHR for the consumable, instrument and reagent area.

·Perform electronic transactions of released products.

·Perform data entry.

·Test consumables for all product lines.

·Record test data accurately and in accordance with established test procedures.

·Perform troubleshooting independently for fluidic and mechanical failures.

·Assist in evaluations and pilot testing.

·Provide department 2nd shift personnel training (QC Test Tech Grade 2-4).

·Test above labor standards.

·Perform label and pallet inspections for Reagent Department products.

·Perform label inspections for other consumable products.

·Responsible for maintaining adequate levels of test and production supplies at the start of the shift.

·Responsible for communicating to direct labor and supervisor information to maximize quality and productivity in the area.

·Communicate with 1st shift for daily work priorities.

Requirements/Experience:

·High school diploma, or equivalent, with a concentration in the sciences with 7 plus years’ experience as a QC tester or inspector working in a medical device, equivalent biotechnology or pharmaceutical environment.

·Associates Degree with a concentration in the sciences with 5 plus years’ experience as a QC tester or inspector working in a medical device, equivalent biotechnology or pharmaceutical environment.

·Undergraduate Degrees with a concentration in the sciences with 3 plus years’ experience as a QC tester or inspector working in a medical device, equivalent biotechnology or pharmaceutical.

·Must have working knowledge of MS Word and Excel, be well-organized and possess high attention to detail. Experience with SAP is a plus.

Qualifications:

·Experience following written protocols or procedures in the execution of daily assigned work and working in a Quality System Regulated (QSR) FDA regulated industry.

·Basic Leadership. Math skills and able to use a calculator. Basic to advanced computer knowledge and use. Use of Microsoft Office Word, Excel, & Access. Knowledge of blood handling (Universal Precautions, storage conditions, etc.). environment. Hours are 3 PM - 11:30 PM Monday through Friday.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.