QC Sample Control, Sr Analyst

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 the Role

The Sr. Analyst, QC Sample Control works independently with limited supervision and guidance from their manager to ensure all samples managed by the Sample Control team are handled and documented in accordance with applicable internal procedures. This role is responsible for handling samples manufactured at FDB Holly Springs, samples and reference materials from external sources, coordinating stability samples and protocols within the sample control team. This role is also responsible for coordinating with key internal stakeholders on the transport of QC samples from Holly Springs to external testing laboratories and support continuous improvement projects and SOP revisions by providing input into the sample handling process. A very high attention to detail and the ability to effectively communicate and function in a fast-paced, highly technical environment is essential to success. This role is included in routine on-call and weekend support, as needed.

What You'll Do

• Supports the setup of the Sample Management lab during Project phase including authoring procedures, sample collection in support of facility qualification, ordering lab supplies for QC department, logbook creation for QC, and additional activities, as needed• Supports sample control team to provide sample collections 7 days a week when in Operations• Supports sample control team to maintain and support equipment alarms during off hours and move samples, as required• Facilitates the movement of QC samples from Manufacturing to the QC labs maintaining sample chain of custody and GMP documentation• Acts as Subject Matter Expert (SME) by overseeing Stability sample sets and pulling samples per protocol and internal procedures• Receives, inspects, and inventories reference materials and samples from external sources• Documents sample receipt, storage, and movement by making entries into Labware LIMS and/or internal sample chain of custody forms or logbooks• Collaborates cross-functionally to address sample issues that arise from manufacturing, laboratories, or the warehouse• Assists in authoring and reviewing SOPs, protocols, reports, change management reports, CAPAs and Trackwise deviations related to Sample Management and Stability Studies• Creates CoA's and result summary reports in support of batch disposition• Supports continuous improvement projects and SOP revisions by providing input into the process and supports associated procedural updates• Maintains sample integrity in all aspects of working with samples and reference materials• 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

Preferred Requirements:

• At least 1 year of experience with the use of Labware LIMS and/or working with a LIMS in a cGMP Quality Control department or in an FDA regulated industry (drugs/biologics)• Experience using Trackwise system• Experience working in a laboratory environment is desired• Basic familiarity with fundamental statistical tools to analyze data in relation to trends results

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

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• 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 use twisting motions.

• Ability to ascend or descend ladders, scaffolding, ramps, etc

• Will work in heights greater than 4 feet

• Will work in small and/or enclosed spaces

• Ability to discern audible cues

• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

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.