QC Laboratory Manager/Director

Purpose: There is an immediate opening for a Quality Control Laboratory Manager/Director with a biopharmaceutical company located in Irvine, CA. The QC Lab Manager/Director will oversee the testing and inspection of products, processes, raw materials and WIP to ensure compliance with appropriate specifications. The environment is fast paced and requires an individual who is multi-task oriented and has hands-on approach to problem solving.

Responsibilities & Duties:
-Provide work direction to and supervision of the QC staff.
-Organize 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.
-Developed raw material and product specifications as needed.
-Developed and maintained 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 database to ease in tracking and trending of relevant QS parameters.

Qualifications:
-Degree in Microbiology, Biology, or Chemistry (advanced study in Microbiology is preferred).
-5-7 years of microbiological laboratory experience
-5-7 years of managerial experience
-Industry experience in tissue culture, biochemical, and microbiological testing methodologies.
-Detailed knowledge of 21 CFR 211-GMP, 21 CFR 820-QSR, ISO 13485, Canadian MDR, MDD-93/42 with emphasis on laboratory testing, material specifications, and related areas.Classification:Direct PlacementCompensation:
65K-85K YearJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
CELL CULTUREContact Information
Contact:Rodriguez,Candi M