Analyst, QC Microbiology

FUJIFILM; Holly Springs (NC); On-site; USD 50,000 - 80,000; Full time

Job summary

Join a leading biopharmaceutical company as a QC Analyst, where you'll play a crucial role in ensuring the quality of life-saving products. This position offers a unique opportunity to work in a state-of-the-art laboratory environment, contributing to the testing of drug substances, products, and raw materials. As part of a dynamic team, you'll engage in various laboratory activities, from sample collection to troubleshooting assays, all while adhering to strict GMP and GLP standards. If you are passionate about making a difference in the biopharma industry and thrive in a collaborative environment, this role is perfect for you.

Qualifications

• 0-2 years of basic GLP laboratory experience required.
• Understanding of GMP, GLP, GDP requirements is essential.
• Knowledge of microbiology laboratory methods preferred.

Responsibilities

• Perform microbial testing of drug substances and products.
• Coordinate testing materials and logistics for sample collection.
• Assist with training and onboarding of new staff as needed.

Skills

Microbiology laboratory methods

Basic GLP laboratory experience

GMP understanding

Troubleshooting laboratory equipment

Data entry skills

Education

BA/BS in scientific discipline

BS in Microbiology, Chemistry, Biochemistry, Biology

Tools

LIMS system

Microbial ID systems (MALDI, MicroSeq)

Trackwise System

Job description

Position Overview

The QC Analyst is responsible for the key operational aspects of the QC Microbiology laboratory. Incumbent will perform microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. Incumbent will be responsible for all associated activities associated with this testing in accordance with written procedures. This position primarily works under minimal supervision as needed. This position will initially be involved in the commissioning activities involved in the construction of a new Biopharmaceutical manufacturing facility and laboratory. Flexibility in job roles and assignments will be required. This may include writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and onboarding of new staff as needed and in addition to regular work duties and assignments.

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.

What You'll Do

1. Collect samples for Environmental monitoring (EM) and Utilities monitoring (UM). Responsible for all sample collection and logistics as needed.
2. Coordinates testing materials and supplies needed for testing.
3. Performs Basic Microbiology laboratory testing following standard procedures for all samples, including but not limited to all in-process samples, raw materials, EM and utilities samples for Bioburden, Endotoxin, plate reading, and microbial identification.
4. Performs sterility testing, isolator qualification and routine operations and maintenance.
5. Sample and data entry into LIMS system.
6. Reviews general lab testing results.
7. Troubleshoots routine assays.
8. General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of analytical instruments, purchasing and receiving of laboratory supplies (media, kits, etc.).
9. Ensures CAPAs are being followed in the laboratory areas.
10. Notifies management and assists with the initiation of events (such as deviations) in the quality systems.
11. Assists with projects as assigned.
12. Performs other duties as assigned.

Minimum Requirements:

• BA/BS in scientific discipline.
• 0-2 years of basic GLP laboratory experience.
• Understanding of GMP, GLP, GDP requirements.
• Knowledgeable in basic sciences and Microbiology laboratory methods and procedures.
• Basic LIMS training.

Preferred Requirements:

• BS within Microbiology, Chemistry, Biochemistry, Biology.
• 2+ years of Intermediate experience in a GMP QC Microbiology Laboratory, knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred.
• Ability to troubleshoot and maintain laboratory equipment and instrumentation.
• Experience with microbial ID systems (MALDI, MicroSeq).
• Intermediate LIMS training.
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP).
• Trackwise System training.
• Lean / 6S training.

Physical and Work Environment 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 conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to sit for prolonged periods of time up to 60 minutes.
• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use 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 ([e-mail]).