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Quality Control Technician - NJ
Ref No.: 16-00919
Location: Warren, New Jersey
Start Date / End Date: 04/08/2016 to 05/05/2017
Manager said the worker must be available to work rotating weekends (the rotation schedule hasn't yet been established). It could be just Sat or Sun, or it could be both Sat & Sun, depending on the production activity (mgr will try to collaborate with worker). The typical weekend hours will be day-shift (8a-5p or thereabouts), and up to 8 hours.

The primary responsibility of this position is the performance of Environmental Monitoring (EM) tasks along with associated bio-analytical testing and reporting for the clinical production of cell therapy products.

Responsibilities will include, but are not limited to, the following:

Environmental Monitoring of cellular therapy production areas:
1. Coordinate with Clinical Production staff for daily EM test schedule and activities.
2. Collection of EM samples (air, surface and personnel) from controlled laboratory areas. Aseptic gowning required for entry into controlled areas.
3. Processing, incubation and evaluation of environmental test samples and incubation chambers.
4. Organization and completion of EM documentation and entering of data into the EM database.
5. Perform trend analysis and lot release reporting of EM data.
6. Analytical testing of cellular therapy products:
a. Perform in-process and final product analysis of clinical release which includes cell counts, viability analysis, and subculture.
b. Assist in analytical trouble shooting and investigations as needed.
c. Update and maintain analytical data in DQC database.
7. Other essential DQC tasks include:
a. Perform raw materials inspection and approval, including placental raw material.
b.. Perform routine control and calibration of DQC instruments and equipment.
c. Participate in investigations as needed.
d. Monitor DQC inventory of reagents and supplies. Re-order as needed. Other tasks as needed.

Skills/Knowledge:
Required:
1. B.S. degree (or equivalent) in Biochemistry, Biology or related discipline
2. 1 year in a Quality Control laboratory or EM/Microbiology experience
Desired:
1. 2+ years in a Quality Control laboratory
2. Cell culture experience
3. Experience with environmental monitoring and aseptic processing Beneficial
4. 2+ years of device, biologics or HCT/P industrial experience
4. Proficient in Microsoft Word/Excel/Access

*****NOTE: For this worker, most critical to Manager is 1 to 2 years actual experience in a GMP clean room environment; AND actual experience with microbiology sampling (environmental monitoring), so please make sure your candidate(s) resume reflects this experience.******