Job Description:

Description

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.

Quality Control Coordinator

San Jose, CA

Your Tasks

• You spearhead sample coordination and receipt from other departments for internal and external testing


• You manage QC sample inventory and retain sample inventory


• You send out test samples to Contract Testing Laboratories (CTL)


• You follow up with CTLs on testing and turnaround times to ensure testing deadlines are met


• You monitor trends in CTL test results


• You work closely with Manufacturing and Process Development to schedule sample submissions to the QC lab


• You effectively communicate updates and results from CTLs


• You inspect all incoming materials through verification of specifications


• You keep accurate and complete records per cGMP


• You ensure all equipment is properly maintained/calibrated


• You perform data entry for tracking & trending of sample management and lab log reports


• You assist management with various projects and metrics as necessary and participate in process improvement such as 5s, Kaizen, & Six Sigma


• You take on other duties as assigned to further the impact of the Quality Control group

Requirements

• Bachelor's Degree and a minimum of 1-2 years' related experience including at least 1 year working in a cGMP environment; or equivalent combination of education and experience.


• Biologic sample coordination experience preferred


• Strong verbal communication skills necessary for interaction with outside contract laboratories.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment

This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a cleanroom  setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, chromatography devices and columns, tangential-flow filtration devices and filters, peristaltic pumps and metering fill pumps, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

Progress prospers with inspiration and curiosity. For 30 years Miltenyi Biotec has been developing products and services that are used in basic research, translational research and cell therapy.  Today we are a team of more than 3,000 scientists, physicians, engineers, marketers and numerous other specialists.

At Miltenyi Biotec, innovative ideas are being turned into cutting edge products. Together, we are passionate about driving biomedical progress towards curing severe diseases.

Miltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Qualifications