Quality Operations Technician
Branchburg is the molecular diagnostics manufacturing engine within Global Operations and a Polymerase Chain Reaction (PCR) center of excellence. As the largest DIA manufacturing site in North America, our teams deliver a broad portfolio of PCR-based in-vitro diagnostic tests. Our operations include reagent and active diagnostic ingredient (ADI) production, filling and packaging.
Our 63-acre site with ~1400 people is currently under expansion, fueled by our culture of agility, innovation and transformation. Each day we focus on delivering the value of Roche Diagnostics to patients around the world.
Summary:
Responsible for routine Quality Control testing, familiar with basic scientific principles, and able to work in a regulated environment. Possesses initiative and a strong commitment to excellence in a fast paced and growing organization. Job requirements will include ability to perform in the aseptic environment. Wear personal protective equipment, such as eye, foot, lab coat, mask, gowning coveralls.
Responsibilities:
- Follows departmental work instructions, SOP’s, OSHA safety regulations and cGMPs to perform assigned tasks. Conducts testing/laboratory experiments utilizing established and published procedures or batch records and technical and theoretical understanding while managing schedules and workflow to accomplish assigned objectives or schedules.
- Assumes responsibility for the accuracy, quality, and timeliness of testing activities. Summarizes batch or experimental results, and reviews conclusions with supervisor/project leader. Communicates results of experiments. Keeps supervisor/project leader informed of work status, particularly of significant findings and results in critical problem areas.
- 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. 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, subassembly and sample testing.
- Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with 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.
- Participates in the design and organization of experiments in conjunction with supervisor. Providing input in writing experimental protocols, investigations and reports may be required. Serves as a resource to Operations or scientific staff.
- Provides input for improving existing laboratory procedures. Assist supervisor in development and implementation of new procedures and evaluating new products and equipment. Assist with generation of written standard operating procedures.
- Other duties as assigned by management.
Requirements:
- Associates degree required; Bachelor's Degree preferred
- Less the 1 year of relevant experience; 2 years relevant experience preferred
- Basic proficiency with MS Word and Excel
Relocation benefits are not available for this job posting.