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FUJIFILM Biotechnologies · 5 hours ago

Senior Specialist 1, Quality Control Lab Support

Holly Springs, NC

Contract

Onsite

Mid, Senior Level

2+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Senior Specialist 1, Quality Control Lab Support works under moderate supervision, supporting QC activities related to investigations, deviations, and compliance, while also participating in project management and process improvement initiatives.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Initiates and authors deviations, CAPA’s, and change controls for the functional groups within QC

Initiates and supports actions for implementation of solutions, process improvements and CAPAs

Participates in customer interactions to gain exposure to topics such as changes, deviations, or other issues and gathers data for status overviews and reports deviations upon completion of training and observation

Reviews and updates stability protocols, sample plans, and specifications related to Drug Substance and Drug Product updates for controlled GMP documents related to sample plans and specifications

Coordinates technical projects and performs problem-solving learning to apply analytical and QC improvement methodologies

Participates in cross-functional team meetings to gain exposure to QC's role in various business processes

Supports QC laboratories in method troubleshooting efforts by collecting data and assisting team members

Owns changes in support of QC laboratories through the change control processes, and compliance-related documentation

Performs continuous improvement activities by developing awareness of quality systems and identifies potential areas for improvement

Provides recommendations to management on KPI’s as needed to evaluate the changes made

Assists team members in Contract Laboratory (CLO), communication roles, learning about issues such as OOS's and deviations and compiles data for performance and status reports Interacts with clients as needed to support change controls and deviations

Documents sample receipt, storage, and movement in Labware LIMS and/or internal sample chain of custody forms or logbooks

Identifies and escalates sample issues to appropriate parties

Performs other duties, as assigned

Qualification

GMP complianceQuality ControlAnalytical instrumentsKNEAT softwareProcess improvementTeam collaborationProblem-solvingCommunication skills

Required

Bachelor's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 2+ years of relevant experience OR

Master's degree in science, preferably Chemistry, Biochemistry, Microbiology, Biology, or Life Sciences relevant scientific discipline with 0 years of relevant experience

1-3 years relevant experience, experience in a GMP environment

Preferred

Experience with KNEAT software

Experience qualifying analytical instruments

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

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)