Lab Tech Ops II

JOB INFORMATION

Job Description Name : Quality Operations Tech - RMD / RSS

Location : All

Job Family : Research & Development

Job Family : Research

Job Profile : Research / Development Technician

Career Band : Manufacturing, Technical and Laboratory Support

Career Level : MT4

FLSA Status : Non-Exempt

US Grade Profile (less Geo) US_DiaRMS_MT4 Research / Development Technician

People Management : Yes

Last Modified Date : 04 / 02 / 2021

JOB 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.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and / or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

Formal Training / Education

Education Level Education

Associate's Degree - REQUIRED

Bachelor's Degree - PREFERRED

Experience

Years of Experience

Less than 1 year of relevant experience. - REQUIRED

2 years of relevant experience. - PREFERRED

Are equivalencies acceptable? Yes equivalent combination of education and work experience accepted

Knowledge, Skills and Abilities

Licenses and Certifications - None

Travel Requirements - As needed Based on business needs