Quality Assurance Technician - GMP Compliance Expert
Resume:
**/**** - **/**** ******* Assurance Technician (QA Technician)
Catalent Inc, Bloomington, IN
My duties are as follows:Number one priority never make production wait, the work comes first! Make sure your SOPs are up-to-date, and you are 100% compliant, Do room In-clearances, Verify challenge sets passed test on the AIM or SAVI (A robotic piece of equipment used to speed up inspection process for more potential production) which the operators run the vials through, and it detects and kicks out product it deems to be rejects. Inspection audits of inspectors to make sure they are doing inspection technique correctly, Pallet verification to verify Master Batch Record numbers match, Item numbers match, and Work Order numbers match, so the right product comes together with the right kit for the client in the proposed room. Releasing of kitted kits from label control, reclassifying good product to samples, to rejects, to put product on Hold and to take product from quarantine to WiP Status so that it may be processed. Doing AQLs (Acceptance Quality Limit), inspection of product, to make sure the AIM or SAVI are doing their jobs of kicking out bad or rejected product. Doing MBR (Master Batch Record) review to check the batch record to make sure there are no errors, and if mistakes are made, document it, take pictures and then e-mail said person that they have a correction to make in a timely manner. Putting together shift reports on spreadsheets, so the next shift has an idea of how production did on the previous shift, Using Excel, Microsoft Word, JDE, Outlook, MES, and Track-wise. And always remember if you don't document what you did or sign your initial set for the task you performed, it didn't happen. Working alongside operators to complete a common goal.
06/2015 - 07/2019 Quality Control
Cook Medical, Bloomington, IN
I started out as QC in Packaging Dept. where I inspected medical devices for defects, i also inspected packaging of medical devices to make sure the seal was good so said device could remain sterile.Then i got transferred to PSS, Cooks sterilization plant.I worked there as a Clerk, got promoted to material handler, then heard about QC position open, so I applied for it and acquired said position due to PAMELA WITVOET
1500 W KIRKWOOD AVE APT 14C, BLOOMINGTON, IN 47404-5091 Phone: 812-***-****
Email: ************@*****.***
Objective
High performing professional with 9 years of experience delivering high-impact work in Pharmaceutical and Medical device Industries. Skilled in developing strong internal and external relationships to facilitate collaborative achievement of organizational goals. Confident in ability to operate effectively in a fast- paced environment and leverage skills in multitasking, attention to detail, and thinking outside the box for inspiration, to enable team success.
Ability Summary
My skill-sets include : Working well with co-workers of all cultures and backgrounds. I enjoy working as a team, working toward the completion of a common goal. I work well under pressure and prefer overtime. As a Document Control Clerk my duties included filing, scanning, auditing, maintenance, and storage of all work orders for medical products for traceability in the case of any recall situation. As a Quality Control Technician my duties were to Inspect vials for defects, make sure all processes were followed at all times, pallet Verifications, room clearances, documentation auditing, inspection audits, typing out daily reports, and making sure every room that was running got everything they needed in a timely manner to keep production at its optimum potential. I am punctual and always arrive early to work. I would greatly appreciate your consideration in hiring me for this position. Employment History
my past work performance and attention to detail. After a few years I was transferred to Park 48 to work as Document Control Clerk where I audited, scanned, filed, maintained, and put in storage work orders for each device made for traceability in case a recall situation arose.
07/2005 - 09/2007 Operator/Product Builder
Boston Scientific, Spencer, IN
The assembly of medical products used in less invasive medical procedures, also the quality inspection of the afore mentioned medical devices...i.e. ligators used to stop internal bleeding of ulcers in the stomach or internal bleeding in the intestines due to inflamed polyps as well as hemorrhoids.
General High School Curriculum
High School Diploma
SULLIVAN HIGH SCHOOL, Sullivan, IN
Education and Training
Detailed References
Josh Ruegsegger, QA Manager/Supervisor
Catalent
Colden Roberts, QA Rep.
Catalent
Jennifer St. Denis, Supervisor
Cook
Zach Orth, Software Division
Crane Naval Base
Bloomington, IN
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