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Supervisor, All QC (Night Shift--6:00 p.m. to 6:00 a.m.)

Full-time

FUJIFILM Biotechnologies

Position Overview

The Supervisor, All QC, 223 shift is responsible for providing day to day supervision, audit readiness, and planning activities for the laboratory. The supervisor will lead an All QC Team that is responsible for performing routine testing required for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC.

Company Overview

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

We're 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 we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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:

Job Description

What You'll Do
  • Provides supervision and scheduling of the 223 shifts in the All-QC laboratory team.
  • Applies expertise in laboratory methodology and compendial requirements for QC testing those spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches.
  • 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.
  • Ability to setup and maintain operations of a QC testing 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.
  • Gather recommendations for enhancements and gaps related to their areas of responsibility and in collaboration with leadership prioritize and implement solutions accordingly.
  • Maintain relationships with site-based customers and global colleagues and provide 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, 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 of their team and peers as applicable. Work 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.
  • Other duties, as assigned.
Minimum Requirements:

  • 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+ years of team management experience
Preferred Requirements:
  • Experience with management of complex projects
  • Experience with leading startup activities and program-forming initiatives, e.g. creation of systems or business processes that support Quality objectives
Physical and Work Environment Requirements:

  • May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
  • Will work in environment operating a motor vehicle or Powered Industrial Truck.
  • Ability to discern audible cues.
  • Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
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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 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 (View email address on hirelifescience.com).
Vacancy posted 8 days ago
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