Sr QC Technician

Job description

Work Schedule Weekend days Environmental 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 materials Job 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 required. 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.