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Work Schedule
Weekend daysEnvironmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Will work with hazardous/toxic materialsJob Description
How will you make an impact?
The Sr. Technician – QC Sample Management will be performing a variety of duties to support Quality Control- Sample Management. Responsibilities of Sample Management include chain of custody, dispensing to laboratories, preventative maintenance of equipment, managing reference standards and critical reagents, shipping samples to sites as applicable, and aliquoting from bulk material. This person is responsible for drafting procedures, participating in special projects, and performing more elaborate functions as .
What will you do?
Documentation of all activities to meet cGMP/cGDP requirements. Maintain compliance in assigned work and follow all safety procedures, to include the use of Person Protective Equipment.
Perform and complete area assigned equipment preventative maintenance as requested.
Performs routine Sample Management tasks: sample pick-up, aliquoting, LIMS, kitting, critical reagent management, sample shipment, sample disposal
Clearly and accurately communicates status of samples (picked up, for testing, for send-out) to cross-functional area teams
Participate in cross-functional activities.
Maintain up to date training records.
Participate in 1-1’s, meetings, attend meetings as necessary to facilitate area needs based on changes, etc. (lean activities).
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
Author Sample Management documents in the site electronic document management system
Investigate and complete investigation of minor sample management deviations
How will you get here?
Education
Minimum two(2) years of college in a Science or Engineering related field (Biology, Biochemistry or Chemistry preferred)
Experience
At least 2years of related experience in biopharmaceutical or pharmaceutical industry preferred
At least 2 years of experience in a cGMP laboratory preferred
Knowledge, Skills, Abilities
Knowledge
Working knowledge of GMP regulations in a GMP environment
Knowledge of cGMP practices and aseptic techniques
Skills
Analytical Skills
MS Office
Strong math skills
Strong prioritization skills
Detail oriented
Results driven
Safety Mindset
Electronic document system
Trackwise or equivalent deviation system
Electronic Sample Management System (LIMS)
SAP
Electronic Laboratory Monitoring (LabWatch or BAS)
Abilities
Able to read, write, and communicate in English
Able to understand and carry out instructions
Reliable
Strong communication (written and verbal)
Effectively multi-task
Able to work in an environment of change
Able to work independently and as part of a team
Able to recognize problems developing, not just occurring
Occasional heavy lifting or moving required
At Thermo Fisher Scientific, each one of our 65,000 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.
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