Thermo Fisher Scientific QC Analyst II, Environmental Monitoring in Lexington, Massachusetts
Job Title: QC Analyst III Environmental Monitoring
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. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
Lexington, MA Facility
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies
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.
Analysis of environmental samples according to Standard Operating Procedures and Test Methods.
Perform bioburden, endotoxin and growth promotion testing.
Develop and assist with aseptic qualification program.
Routine environmental monitoring of air, surface, water, gas and steam systems and assessment of results.
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
Complete GMP and Safety Training
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 training and on the job training for new employees.
Perform assay review achieved with assay competency.
Completes tasks where judgment is required in resolving problems & making recommendations.
Provides frequent feedback to supervisor/manager.
Requires BS in Microbiology or related life sciences discipline.
At least 1+ years of relevant experience within the pharmaceutical or biotechnology industry along with prior experience in a manufacturing environment and knowledge of aseptic technique and gowning procedures is preferred.
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.
Ability to investigate routine environmental monitoring excursions.
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.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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.