Supervisor, All QC (Day Shift)

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: 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.

What Youll 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 individuals 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 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.

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.

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 ().