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FUJIFILM Biotechnologies · 1 week ago

Supervisor, QC Microbiology

Holly Springs, NC

Full-time

Onsite

Mid, Senior Level

4+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Supervisor, QC Microbiology, is responsible for providing day-to-day supervision of the QC Microbiology laboratory team, ensuring audit readiness, and planning activities for the laboratory.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Provides day-to-day supervision and scheduling of the QC Microbiology laboratory team

Applies expertise in laboratory methodology and compendial requirements for QC Microbiology testing and acts as primary point of contact for their team and first-line escalation point in areas of their responsibility

Leads team to meet project deliverables

Demonstrates ability to set up and maintain operations of a QC Microbiology laboratory

Assists senior management with resource planning and budget-related tasks

Ensures efficient team scheduling, management of sample collection and testing to meet deliverables on time

Gathers recommendations for enhancements and gaps related to their areas of responsibility and, in collaboration with leadership, prioritizes and implements solutions accordingly

Maintains relationships with site-based customers and global colleagues and provides updates to leadership as requested

Ensures allocation and planning of adequate resources for laboratory testing activities, QA support activities, and provides technical guidance to the team

Leads cross-functional teams to achieve operational readiness objectives and new product introduction goals using a risk-based, right-size approach

Leads or guides laboratory staff in the investigation of lab deviations, excursions, and implementation of CAPAs as needed

Serves as Subject Matter Expert (SME) in audits and inspections for the laboratory. Prepares and guides laboratory team to ensure audit readiness

Establishes and maintains internal and external training goals for self and team to ensure compliance with cGMPs and regulatory requirements

Provides training, coaching, and mentorship to their team and peers as applicable. Works with their team to identify areas of improvement, reduce blind spots, and give opportunities for increasing responsibility as appropriate for each individual's career objectives

Administers company policies such as time off, shift work, and inclement weather that directly impact employees

Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)

Coaches and guides direct reports to foster professional development

Participates in the recruitment process and retention strategies to attract and retain talent, as needed

Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution

Performs other duties, as assigned

Qualification

QC Microbiology expertiseGMP environment experienceLIMSValidation softwarePeople managementCompendial microbial methodsProject managementTrainingMentorshipCross-functional leadershipCommunication skills

Required

Bachelors in Life Sciences (Biology or Microbiology) with 4+ years of relevant experience OR

Masters in Life Sciences (Biology or Microbiology) with 2+ years of relevant experience

2-3 years of people management experience

Experience working in a regulated GMP environment

Experience and working knowledge of LIMS, Smartsheet, Track wise, Master Control, and/or Kneat validation software

Experience with management of complex projects

Experience and understanding of compendial microbial methods, Data Integrity, and application of regulatory requirements for QC Microbiology

Experience with laboratory equipment, utilities qualification, environmental monitoring qualification, quality systems, automation, IT systems, and/or validation of methodologies

Preferred

Experience leading teams in a laboratory setting

Experience and advanced understanding of large-scale biomanufacturing processes

Experience in leading startup activities and program-forming initiatives, e.g., creation of systems or business processes that support Quality objectives

Experience and familiarity with Technology Transfer and/or Product Commercialization processes

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)