Sr Analyst 1, QC Microbiology

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 13 hours ago

Vacancies: 1 Vacancy

Department:

Quality Control

Job Summary

Position Overview

The Sr. Analyst 1 QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1 QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance drug product EM/UM and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed consults with management on key decisions.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs North Carolina. By end of 2025 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were looking for passionate mission-driven people to help us realize this exciting vision and deliver the next vaccine cure or therapy. We offer a dynamic work environment and were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

About This Role

Executes advanced lab testing and support for all laboratory assays for all samples and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test
Leads sample collection and manages sample logistics for testing
Supports testing for all qualification and study directed testing
Supports investigation of routine OOS assays and events
Conducts qualification and validation protocols
Leads sterility testing
Reviews intermediate lab testing results
Troubleshoots complex assays
Writes and assists with document preparation and review
Manages project timelines
Assists management with training and on-boarding of new staff as needed
Embraces LEAN lab and six sigma principles and applies them to laboratory processes
Champions projects and project management as assigned
Performs other duties as assigned

Minimum Qualifications

Bachelors with 2 years of relevant Microbiology experience OR
Masters with 0 years of experience Experience with aseptic production & support
1-3 years in a GMP environment Advanced understanding of GMP GLP GDP requirements
Advanced knowledge in Microbiology theory
Advanced knowledge of Microbiology testing and laboratory experience
LIMS experience
Experience with document control including reviewing and editing technical documents
LEAN lab and Six Sigma training and/or certification
Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
Intermediate LIMS software training
Knowledge or training of FDA regulations (cGMP cGLP cGDP)

Preferred Qualifications

Masters with 1 years of experience
4 years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage
Advanced experience in a GMP QC Microbiology Laboratory advanced knowledge of all compendial test methods (Bioburden Endotoxin Sterility testing)
Advanced experience with microbial ID systems ability to troubleshoot complex equipment and instrumentation (MALDI MicroSeq)
Advanced LIMS / Trackwise software training
Experience working within a QC laboratory environment commissioning Pharmaceutical and/or laboratory facilities

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

PHYSICAL REQUIREMENTS PHYSICAL DEMANDS

Will work in environment which may necessitate respiratory protection X No Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color. No X Yes

WORKING ENVIRONMENT PHYSICAL DEMANDS

Ability to ascend or descend ladders scaffolding ramps etc. No X Yes

Ability to stand for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes may specify frequency/duration: up tominutes)

Ability to sit for prolonged periods of time. No X Yes Daily up to 60 minutes (If yes may specify frequency/duration: up tominutes)

Ability to conduct activities using repetitive motions that include writs hands and/or fingers. No X Yes

Ability to operate machinery and/or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes X 10 lbs. 33 lbs.

Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions. No X Yes

ENVIRONMENTAL CONDITIONS

Will work in warm/cold environments X No Yes Range (If yes specify approximate temperature ranges.)

Will work in outdoor elements such as precipitation and wind. X No Yes

Will work in small and/or enclosed spaces. No X Yes

Will work in heights greater than 4 feet. No X Yes

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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 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 committedto 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 ().

Required Experience:

Senior IC

Position OverviewThe Sr. Analyst 1 QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Analyst 1 QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance drug product EM/UM and raw mater...