Senior QC Microbiologist II - El Segundo, CA | Biospace
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Senior QC Microbiologist II

Apex Life Sciences

Location:
El Segundo, CA
Posted Date:
8/17/2017
Position Type:
Full time
Job Code:
776804
Salary:
$70,000-$80,000
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Cancer, Microbiology, Validation,

Job Description

ESPONSIBILITIES (INCLUDE BUT ARE NOT LIMITED TO):

Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability)
Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state
Develop, revise and review SOPs, qualification/validation protocols and reports.
Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures  
Monitor the GMP systems currently in place to ensure compliance with documented policies
Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Gather metric information for use in continuous improvement of areas of responsibility.
Perform other duties as assigned.

Requirements

Bachelor's degree or advanced degree in Microbiology or related discipline
Six to 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of  3 years’ experience with method and equipment validation within the biotechnology or pharmaceutical industry
The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell therapy product
Strong knowledge of  Environmental Monitoring requirements and tests (viable and  non-viable),   Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP)
Experience in performing risk assessments
Strong knowledge of Quality Control processes, GMPs,  and Microbiological method validation
Extensive experience in conducting laboratory and environmental excursion investigations.
Strong knowledge of  Equipment IQ/OQ/PQ/PV
Proficient in MS Word, Excel, Power Point and other applications
Ability to communicate and work independently with scientific/technical personnel.