QC Micro Analyst III - Full-time / Part-time

Must Have:
cGMP training/GXP documentation
Aseptic technique
Environmental Monitoring
Minimum 5 years' experience in Microbiology

Preferred experience with:
BacT
Pyros Kinetic Endotoxin testing
MODA (lims system)
Gram Stain
Sterility and Bioburden
SOP writing


The QC Analyst III/IV performs complex quality activities in support of product production and releases. The position has interaction with other internal departments, including Apligraf Production, FortaFlex Production, Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interaction with external entities including contractors and suppliers. The QC Analyst III/IV performs a wide variety of complex activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.
KEY RESPONSIBILITIES

* Coordinate endotoxin, microbiologic, and water testing.
* Perform and/or read environmental, personnel monitoring.
* Perform and coordinate Bioburden and sterility testing of raw materials, and in-process samples (including microbiological, raw material and water samples of cell based protein products).
* Perform microbiology release testing of final product.
* Prepare and send out samples for microbiological identification and/or mycoplasma testing.
* Perform visual inspection of finished product.
* Generate trend reports as they relate to quality testing.
* Revise SOPs.
* Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood.
* Identify and implement issues and opportunities for improvements.
* Participate extensively in high-level quality systems programs (CAPA, Exception Reporting, OOS's, etc.).

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .

Aerotek is acting as an Employment Agency in relation to this vacancy.