Quality Control Lab Manager/Director

Irvine Scientific, located in Orange County, is a technological leader in the production of tissue culture and reproductive media.  We are seeking a Quality Control Lab Manager/Director to oversee the testing and inspection of products, processes, raw materials and WIP to ensure compliance with appropriate specifications.  This is a fast paced lab and requires an individual who is multi-task oriented, has a hands-on approach to problem solving and possesses effective communication skills.

 

Responsibilities include but are not limited to:Provide work direction to and supervision of the QC staffOrganize and maintain orderly flow of required testing, including notification of progress to all affected departments in a timely manner.Provide suggestions to improve existing test methodologies and/or develop new test protocols as needed to maintain state of the art testing methodologies.Develop raw material and product specifications as needed.Develop and maintain appropriate product retention and stability dating programs.Monitor and maintain QC laboratory equipment and process validation status.Provide for environmental monitoring of required areas; trend analysis of such data; report variances with recommended solutions.Maintenance and development of databases to ease in tracking and trending of relevant Quality System parameters.

 Qualifications:Degree in microbiology, biology, or chemistry (advanced study in microbiology preferred).5-7 years of microbiological lab experience and managerial experience.

? Good skills in tissue culture, biochemical, and microbiological testing methodologies.

? Demonstrated supervisory skills.Detailed understanding of 21CFR211 ? cGMP, 21CFR820 - QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas.

 

We offer a competitive benefits package including medical, dental, life insurance, 401k, and flexible spending accounts.

 

To Apply:  Please email resume in PDF or MS Word format with salary requirements to IS_HR@irvinesci.com .  No phone calls please.

 

To find out more about Irvine Scientific, please visit our website at www.irvinesci.com.Irvine Scientific is an equal opportunity employer.