Instrument Lifecycle Specialist, Quality Control

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World. 

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide. 

Position Summary

The Instrument Lifecycle team provides operational and technical support to the QC/MC laboratories by providing lifecycle support for QC/MC analytical instrumentation and equipment. This enables the lab to operate efficiently and ensure capacity for incoming sample volumes. The QC Instrumentation Lifecycle Specialist is a member of Instrument Lifecycle team responsible for supporting the instrument/equipment program in the QC/MC laboratories.

Duties & Responsibilities

• Initiate and complete commissioning documentation, including creation of templates, and execution of implementation requirements.
• Assist with periodic reviews of computer system validation and instrument qualifications.
• Assist with the execution of qualification/validation activities for commissioning of new instrumentation.
• Execute performance verifications to ensure instrument performance.
• Assist with the creation of documentation for instrument qualification and computer software/hardware validation protocols and final reports in conjunction with cross functional subject matter experts and quality assurance.
• Maintain comprehensive inventory of instrument and equipment with the laboratory and status.
• Support the use of the Computerized Maintenance Management System (CMMS), including the submission of work orders for repair.
• Support the calibration program by closing calibration work orders, escorting vendors, assisting area owners, and responding to calibration alerts and ad hoc requests as assigned.
• Assist with the scheduling of vendors for service, maintenance, or other issues.
• Assist with calibration failure investigations, including performance of instrument deficiencies to support timely return to service.
• Support/update instrumentation information in the Electronic Laboratory Notebook (ELN) and other laboratory systems.
• Assist in purchases of instrumentation by gathering quotes and collaborating with laboratory.

Education & Experience

Minimum of BS in relevant scientific or computer area with 1-3 years’ experience in the biopharmaceutical industry or equivalent combination of education and experience.

Knowledge, Skills, Abilities

• Working knowledge of laboratory systems much as Labware, Maximo and other software programs, including Microsoft Office Applications, preferred.
• Knowledge base of regulatory requirements for cGMP, computerized analytical systems, i.e. 21 CFR part 11, cGMP, validation, and retirement preferred.
• Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Interpersonal, oral and written communication skills are essential.
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility.
• Ability to work independently with minimal supervision.
• Contribute to a team based, collaborative and positive environment, clarity of purpose and Minimum of BS in relevant scientific or computer area with 1-3 years’ experience in the biopharmaceutical industry or equivalent combination of education and experience.
• High commitment to business goals.

Physical Demands

Frequent repeated motions such as lifting, bending, twisting, squatting, walking, climbing on stepstools, and reaching is required. This role also requires frequent unassisted lifting (not to exceed 50 lbs). Office-based work requires sitting. Repetitive use of arms/hands/wrists, especially when working with a computer.

Work Environment

This position is a primarily an office-based position, however, requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE). This position is based indoors. You will be primarily working with others, however, will also work independently and alone at times. Walking within and between buildings is required to enter laboratories and collaborate with others. This position is a team-based position that may require weekends, holidays, and off shift work.

Target Bonus

8%

Work Location:

East Syracuse, NY 

We are an Equal Employment Opportunity (“EEO”) Employer. 

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!