Sr. Specialist 1, QC Instrumentation

Overview

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

The work we do at FDB 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 FDB 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.

 

External US

About This Role

 

The QC Sr. Specialist 1, Instrumentation works independently to perform routine operations, continuous improvement, and life-cycle management of the QC analytical instrumentation program. This role ensures compliance of QC analytical instrumentation with Data Integrity standards in accordance with regulatory guidelines and company policies and procedures. This role ensures the performance of routine maintenance, completing periodic reviews of  QC analytical instrumentation to confirm compliance and correct deviations and excursions. The role supports stakeholders with issues and guidance related to QC analytical instruments. This role is included in routine on-call and weekend support, as needed.

 

What You’ll Do

 

• Executes the qualification, routine operation, maintenance, continuous improvement and decommissioning of QC analytical instrumentation.• Ensures all QC equipment and instruments adhere to regulatory guidelines and site policies.• Authors and reviews SOPs, technical reports, user requirements and functional specifications, and KNEAT protocols and reports.• Supports data integrity initiatives related to analytical instruments.• Recommends appropriate user roles and privileges for data integrity (where applicable), write instrument operation instructions and preventative maintenance plans.• Works with vendors performing maintenance activities on QC analytical instruments.• Completes periodic reviews of QC instruments and associated instrument control software.• Identifies and follows-up on excursions and deviations and initiate corrective and preventative actions (CAPAs) related to analytical instruments.• Supports stakeholders, including end users, with issues and guidance related to QC analytical instruments.• Works cross functionally with all end users, Validation Team, Labware Specialists, and Quality Assurance.• Performs other duties, as assigned

 

Minimum Requirements:

 

• Bachelor’s degree in Science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 3+ years of relevant experience OR• Master’s degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 1 year of relevant experience• 1- 3 years relevant experience, experience in a GMP environment• Hands on experience with analytical instrumentation associated with  the following technologies: UPLC/HPLC, capillary  electrophoresis/imaged capillary isoelectric focusing, gel electrophoresis/Western blot, plate readers, qPCR, spectrophotometry, and mass spectrometry.

 

Preferred Requirements:

 

• Experience with KNEAT software 

• Experience qualifying analytical instruments

• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment

 

 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 ti