Associate I, QC Micro

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: April 6, 2021

Job Description:

When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. **Location/Division Specific Information** Viral Vector Services (VVS) at the Cambridge, MA Facility **How will you make an impact?** Act as a team member of the Quality Control department to support routine environmental monitoring of air, surface, and clean utilities for manufacturing of in-process and final product drug lots for customers. Compiles data for documentation of test procedures and prepares reports. Provides QC support throughout Brammer Bio (e.g. projects, product transfers and regulatory inspections). Ensures all testing processes, monitoring, and departmental documentation meet Brammer Bio and cGMP regulatory standards. **What will you do?** + Analyst will perform analysis of environmental monitoring test results according to Standard Operating Procedures (SOPs) and Test Methods and provides on-time, high quality results to meet Manufacturing demands. + Routine environmental monitoring of air, surface, water, gas and steam systems + Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs). + General lab support including housekeeping, equipment maintenance, inventory of supplies, etc + Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next. + Perform routine testing with supervisor direction + Perform assay review achieved with assay competency with supervisor direction + Provides frequent feedback to supervisor/manager. **Education** Requires BS or equivalent experience in clean room operations. **Experience** At least 0-2 years of related experience or equivalent combination of education & experience. **Knowledge, Skills, Abilities** + Ability to communicate at all levels and across various functions + Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure. + Completes tasks where judgment is required in resolving problems and recommendations. + Frequent use & general knowledge of industry practices, techniques and standards. + Strong interpersonal and communications skills; written and oral. + Understanding of applicable regulatory requirements. + Must work well on a team and be able to trouble shoot and problem solve in a cross functional team setting. + Must be proactive, action oriented and have the ability to adapt to a change. + Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage. + Shift is Sunday - Wednesday 7:30am - 6pm Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Keywords: Thermo Fisher Scientific, Cambridge , Associate I, QC Micro, Other , Cambridge, Massachusetts