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Quality Control Technician - NJ
Ref No.: 16-00918
Location: warren, New Jersey
Start Date / End Date: 04/08/2016 to 05/09/2017
This QC Tech position is slightly different (more analytical) than JP#4002. Reference below "NOTE ".
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 bio-analytical testing of cell therapy products, which includes cell counting, flow cytometry, and polymerase chain reaction (PCR). Additional responsibilities may include, but are not limited to, the following:

Environmental Monitoring of cellular therapy production areas:
1. Collection of EM samples (air, surface and personnel) from controlled laboratory areas. Aseptic gowning required for entry into controlled areas.
2. Processing, incubation and evaluation of environmental test samples and incubation chambers.
3. Organization and completion of EM documentation and entering of data into the EM database.
4. Perform trend analysis and lot release reporting of EM data.
5. Assist in analytical trouble shooting and investigations as needed.
6. Update and maintain analytical data in DQC database.
7. Other essential DQC tasks include:
a. Perform routine control and calibration of DQC instruments and equipment.
b. Participate in investigations as needed.
c. Monitor DQC inventory of reagents and supplies. Re-order as needed.
d. 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 and experience with cell therapy products
1. 2+ years in a Quality Control laboratory
2. Flow cytometry and PCR experience
3. Experience with environmental monitoring and aseptic processing Beneficial
4. 2+ years of device, biologics or HCT/P industrial experience
5. Proficient in Microsoft Word/Excel/Access

*****NOTE: For this worker, most critical to Manager is actual experience with PCR test methodology; AND actual experience with flow cytometry, so please make sure your candidate(s) resume reflects this experience.******