Sample Management Coordinator *PC 1225

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.

Sample Management Coordinator

San Jose, CA

Your Tasks:

This position is primarily responsible for leading the receiving and sample management activities for all samples from Manufacturing to Quality Control. In this role, you will also be responsible for managing all QC sample shipping and testing at contract labs while leading continuous improvement projects within assigned unit and working with other functional groups to plan sampling for different client projects. Additionally, you will support the inventory management, laboratory, housekeeping, and writing SOPs and you will occasionally adjust schedule, to support production schedule.

Essential Duties and Responsibilities:

• Lead sample coordination and receipt activities from other departments for internal and external testing.
• Manage QC sample inventory and retain inventory.
• Create Purchase Requisitions and work with Finance to obtain Purchase Orders for Contract Testing Laboratories (CTL). Send out test samples to CTLs.
• Act as a project coordinator for implementing new testing to contract labs and for new improvement initiatives in assigned business unit (e.g. electronic systems).
• Follow up with CTLs on testing and turnaround times to ensure testing and project deadlines are met.
• Trend CTL test results and provides metrics for CTL testing.
• Work closely with Manufacturing and Process Development to schedule sample submissions to the QC lab.
• Communicate updates and results from CTLs.
• Maintain accurate and complete records per cGMP guidelines.
• Train other team members on the sample management roles.
• Initiate deviations and OOS as needed.
• Assist management with various projects and metrics as needed.
• Participate in process improvement initiatives (e.g. 5s, Kaizen, Six Sigma).
• Other duties as assigned.

Requirements:

• Bachelor's Degree in a Microbiology, Biology, Engineering or related discipline; 0-2 years' experience in a biotechnology or pharmaceutical related field, including knowledge of a GMP environment; or equivalent combination of education and experience.
• Prefer experience with biologic sample coordination.
• Day Shift - Onsite. Schedule's will occasionally adjust, to support production schedule and some overtime is expected.
• Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

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 10 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:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work in this role is done in Temperature Controlled office environments where the noise level in the work environment is usually moderate.

Miltenyi Biotec is expanding and evolving. Our culture is one that empowers you to embrace new challenges and influence change. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

We empower great science. For over 30 years, Miltenyi Biotec has provided innovative tools, instruments, and solutions that advance biomedical research and cellular therapy. We are 3,000 scientists, engineers, physicians, support specialists, marketers and more – all dedicated to improving scientific understanding and impacting human lives. At our headquarters campus and offices worldwide, fresh ideas become unique products.

The anticipated base salary range has been established at $57,720-$63,440/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

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

Miltenyi Biotec, Inc. participates in E-Verify.