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21 days old

QC Microbiology III- permanent position

Kelly Services
Allendale, NJ 07401
**Permanent position- QC Microbiology Engineer- Level 3**



**Bergen County, NJ 07401**



Overview:




+ The QC Microbiology Engineer III will report into the Associate Manager of QC Microbiology and will serve as a support role to clinical and/or commercial production.

+ Coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the QC Microbiology Engineer III will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin.



Essential Functions and Responsibilities:




+ Documentation according to written SOP in accordance to cGMP and GDP.

+ Coordinates microbiological testing data for batch release

+ Participation in project/client meetings and communications,

+ Authoring/revising SOP, Work Instructions, Forms, and Protocols

+ Review of investigations and documentation of non-confirming events and environmental excursions. Coordinates work orders.

+ Apply expertise of compliance requirements to maintain an inspection-ready state.

+ Participate and act as subject matter expert during audits/inspections

+ Develop and train QC Microbiology Engineer II on relevant business processes

+ Processing of purchase orders for outsourced testing and lab supplies





Qualifications:




+ Minimum 6-7 years of experience in Microbiology. Cell therapy experience preferred.

+ Familiarity with ISO and EU standards. MODA/LIMS experience.

+ Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review

+ Strong technical writing skill and technical training experience.

+ Microsoft Visio, Netsuite and Maximo Asset Management System (preferred)

+ Microbiology testing or within the biopharmaceutical industry experience preferred.

+ Must be flexible with work schedule, ability to work weekend or holidays as needed.



Working Environment:




+ While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens.

+ Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

+ Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen.






**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-28 Expires: 2020-09-28

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QC Microbiology III- permanent position

Kelly Services
Allendale, NJ 07401

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