· Job facts
Performs production and testing of bulk manufacturing reagents at a high level consistent with Roche quality standards. Follows all department work instructions, standard operating procedures, OSHA safety regulations and executes all manufacturing activities in accordance with cGMP/cGDP/cGLP guidelines. Performs environmental monitoring for manufacturing areas before and during manufacturing activities. Monitors laboratory supply inventory; replenishes lab supplies as needed. Performs general/routine laboratory maintenance/upkeep. Communicates and interfaces directly with filling personnel to coordinate filling of completed bulk reagents. Communicates and interfaces directly with internal groups to ensure that laboratory equipment maintenance and calibration are completed as scheduled. Lifting requirements up to 50lbs.
Must be able to work in a clean room environment. Must be able to wear protective equipment, such as eye, foot, lab coat, and dust mask
· Perform production and testing including production support duties for Operations ensuring quality of production and/or lab testing is completed by the department.
· Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks.
· Monitor and oversee lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
· Duties may include handling of hazardous materials in activities described above. Depending upon area of assignment or primary focus, may maintain departmental stock rooms, keep labs stocked, prepare buffers as needed/required which may also include performing direct production or testing activities.
· Maintain stock rooms and laboratories or work areas properly stocked with daily supplies to include the scheduling of repairs and preventative maintenance as necessary and report malfunctions to supervisor.
· Monitor lab supply inventory, generate expense purchase requisitions, if applicable, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
· Duties may include handling of hazardous materials as described above. Depending upon area of assignment or primary focus, may perform various manufacturing and testing duties in addition to maintaining departmental stock rooms, log books, preparing buffers as needed/required which may also include, performing direct manufacturing activities such as bulk formulation, filling, sub-assembly and sample testing.
· Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform to established practices.
· Attends required training classes and participates in on-the-job training.
· Manages schedules, workload and establishes priorities using inputs from business requirements, SAP, and/or internal customer needs.
· Bachelor's degree preferred
· 0-2 Years General laboratory experience and basic GMP Knowledge required
· Demonstrates ability to follow Standard Operating Procedures (SOP) and Directions for Testing (DFT) documents. Demonstrates competence in reading and completing charts, forms, and other documents. Ability to use personal computer with basic word-processing and spreadsheet applications. Good written and verbal communication skills highly desirable
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > General Manufacturing
· Who we are
At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.