validation Specialist III

Job Description

Location:: Allston, MA

Visa Status:: Any work visa (Visa sponsorship available)

Salary::$55-60/hr.

Duration::

Job Description:

Duties: QC Instrumentation Services is responsible for the management and implementation of the Laboratory Equipment Qualification system. Its goal to efficiently specify/source laboratory equipment and execute qualifications in a timely manner to enable QC Microbiology and QC Chemistry departments to execute their functions using equipment which meets the intended use. This position is responsible for qualifying computerized instrument associated software used for analytical and microbiological testing at the Sanofi Genzyme Allston Landing Facility. Responsibilities include execution and coordination of activities to qualify software, writing protocols, reports, and procedures, coordinating the purchase, commissioning, and introduction to the QC laboratory. Establish and maintain Equipment History Files. Coordinate all services provided by vendors, ensuring vendors meet all site requirements. Schedule/plan/execute validation activities.
 
 
Skills: Demonstrated scientific-technical writing ability.
 
Knowledge of USP 1058 and GAMP methodology
 
Knowledge of 21CFR Parts 11, 210, 211, 600 and 610 and Annex 11.
 
Previous hands-on experience performing software validation compliant with 21CFR Part 11 and Annex 11.
Keywords:
Education: Bachelor's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of relevant experience.
Or
Master's Degree in Chemistry, Life Sciences, or Engineering discipline and 5 years of relevant experience.
 
Skills and Experience:
Required Skills: 
CHEMISTRY
LABORATORY
LIFE SCIENCES
SOFTWARE VALIDATION
USP
Additional Skills:
WRITING PROTOCOLS
EQUIPMENT SALES
INSTRUMENTATION
ITS
LABORATORY EQUIPMENT
MICROBIOLOGICAL
Languages:
English
        Read
        Write
        Speak
Minimum Degree Required: Bachelor's Degree

Qualification::