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15 days old

QC Microbiology Manager

Kelly Services
Bloomsbury, NJ 08804
**Quality Control Microbiology Manager**



1st Shift



Bloomsbury NJ



Permanent/Salaried/Bonus eligible






**Position Overview:**



Manages the QC Microbiology laboratory operations in Bloomsbury, NJ. This includes management of all daily activities, staff performance, coaching, and developing staff. Coordinate microbiological analytical activities including release testing, method transfers, and stability studies for an aseptic production facility.



**Scope:**




+ Responsible for Microbiological testing and release of commercial/marketed products

+ Responsible for the transfer of microbiological methods from R&D and between sites

+ Mentor, coach, and develop the skills and capabilities of staff

+ Investigate, and provide thorough scientific justification for all out of specification or atypical test results

+ Maintain all laboratory activities within compliance to cGMPs, and Quality procedures

+ Interface with contract laboratories, as a technical expert and business contact

+ Manage and report on departmental Key Performance Indicators (KPI)

+ Provide Microbiological expertise and guidance on all relevant scientific and technical issues



**Responsibilities may include** :




+ Responsible for planning and execution of routine release, stability, and investigational testing for sterility and endotoxins

+ Prepare, review, and approve departmental SOPs

+ Maintain accurate records, in compliance with cGMP and documentation policies

+ Implement continuous improvement initiatives, including new instrumentation or methods, to enhance throughput, efficiency, and compliance in the laboratory

+ Provide scientifically sound investigations of OOS results

+ Provide Quality and Compliance oversite within the microbiology laboratories

+ Effectively communicate with, and support Quality and Operations functions

+ Manage laboratory budgets

+ Responsible for implementation and maintenance of the laboratory safety program






**Qualifications:**







+ Legally authorized to work in the job posting country

+ B.S. or M.S. degree in Microbiology or related field required

+ 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry

+ 3 years of supervisory or management experience required

+ Experience in sterile manufacturing preferred

+ Experience and expertise in USP <71> Sterility Testing, with an emphasis in Scan RDI instrumentation and methods, including method development and validation

+ Expertise with USP <85> Endotoxin testing, including interpretation of results, investigation, and troubleshooting

+ Thorough understanding of 21CFR Part 211 cGMP requirements for sterile drug products with emphasis on 2004 Guidance for Sterile Drug Products produced by Aseptic Processing






**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/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-01-11 Expires: 2021-02-25

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QC Microbiology Manager

Kelly Services
Bloomsbury, NJ 08804

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