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FUJIFILM Biotechnologies · 2 weeks ago

Associate 2, QC Microbiology (Wednesday to Saturday 2pm - 12am)

Triangle, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

FUJIFILM Biotechnologies is at the forefront of advancing tomorrow’s medicines. The Associate 2, Quality Control Microbiology is responsible for performing routine microbiological testing and supporting laboratory operations to ensure compliance and quality in manufacturing processes.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Provides facility support through the collection and testing of site clean utilities (e.g., water, stem, and compressed gases)

Performs microbiological testing (e.g., Bioburden, Endotoxin, and Growth Promotion) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches

Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)

Performs environmental monitoring of controlled manufacturing environments

Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance

Assists management with technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems

Identifies and solves problems while consulting and under the direction of management

Assists with laboratory equipment qualification and validation activities

Participates in project developments from concept through execution, ensuring alignment with organizational goals. Performs other duties, as assigned

Qualification

Microbiology testingCGMP complianceData management systemsAseptic techniquesTechnical writingLean lab principlesSix Sigma principlesEffective communicationProblem-solving skillsCollaboration skills

Required

High School Diploma/GED with 6 years of Microbiology experience; or

Associate's degree in Life Science, Pharmaceutical, or related field with 2-4 years of Microbiology experience; or

Bachelor's degree in Life Science or Biology with 1-2 years of Microbiology experience

Experience with data management systems (e.g., LIMS, TrackWise)

Knowledge of aseptic techniques and behaviors

Effective communication, both written and verbal

Technical writing and problem-solving skills

Ability to complete work both independently and under guidance from Supervision

Ability to systematically approach daily tasks

Ability to effectively collaborate with coworkers and internal clients

Knowledge of United States Pharmacopeia and European Pharmacopeia

Ability to support audit readiness for the laboratory

Willingness to incorporate lean lab and six sigma principles into the work environment

Ability to manage and complete tasks according to a structured plan

Knowledge and familiarity with data management systems (e.g., TrackWise, LIMS) and capability to learn basic use and navigation within the systems

Must be flexible to support 24/7 manufacturing facility

Ability to stand for prolonged periods of time 60 to 120 minutes

Ability to sit for prolonged periods of time 60 to 120 minutes

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers

Ability to operate machinery and/or power tools

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

Preferred

2+ years of CGMP laboratory experience

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (1)