Sr. Specialist 2, QC Instrumentation

The Sr. Specialist 2, QC Instrumentation manages routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program with minimal supervision. This role ensures compliance with Data Integrity standards in alignment with regulatory guidelines and company policies. The Sr. Specialist executes and monitors the performance of routine maintenance, performs periodic reviews to ensure continued compliance, and leads the identification and correction of deviations. The role provides guidance to stakeholders and addresses issues related to QC analytical instruments. It also includes periodic on-call and weekend support as needed

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You’ll Do

• Manages the qualification, routine operation, maintenance, continuous improvement, and decommissioning of QC analytical instrumentation.
• Ensures QC equipment and instruments are adhered to regulatory guidelines and site policies.
• Develops, authors, and reviews SOPs, technical reports, user requirements, functional specifications, and KNEAT protocols and reports.
• Leads data integrity initiatives for analytical instruments.
• Recommends user roles and privileges for data integrity and designs instrument operation instructions and preventative maintenance plans.
• Partners with vendors to oversee maintenance activities for QC analytical instruments.
• Executes and evaluates periodic reviews of QC instruments and their control software.
• Initiates and oversees follow-up on excursions and deviations and manages corrective and preventative actions (CAPAs) related to analytical instruments.
• Partners with cross-functional teams, including end users, Validation, Labware Specialists, and Quality Assurance, to ensure QC instrumentation operates effectively.
• Monitors ongoing performance and drives improvements to QC instrumentation processes.
• Manages a variety of routine tasks while effectively addressing complex situations as they arise.
• Performs other duties as assigned.
  
  

Minimum Requirements:

• Bachelor’s in chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 6 years of analytical laboratory experience preferably in biotechnology, Pharma, Contract Research Organization (CRO), or Contract Laboratory Organization (CLO) OR
• Master’s in chemistry, Biochemistry, Biological Sciences, Engineering, or related science field with 3 years of experience, OR
• 1-3 years’ experience in a GMP environment
• Prior Hands-on experience with analytical instrumentation, including but not limit top UPLC/HPLC (Ultra/High-Performance Liquid Chromatography), Capillary Electrophoresis/Imaged Capillary Isoelectric Focusing (iCIEF), Gel Electrophoresis/Western Blot, Plate Readers, qPCR (Quantitative Polymerase Chain Reaction), Spectrophotometry, Mass Spectrometry.
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system
  
  

Preferred Requirements:

• Experience qualifying analytical instruments.
• Experience with Customer Relationship Management
• Experience using quality systems (e.g., deviation management system, change control, corrective and preventive action (CAPA), document management system)
  
  

Working Conditions & Physical Requirements:

• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc
• Ability to stand for prolonged periods of time, up to 60 minutes
• Ability to sit for prolonged periods of time, up to 60 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and using twisting motions
• Will work in small and/or enclosed spaces
• Will work in heights greater than 4 feet
  
  

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).