Supervisor, All QC (Day Shift)

About the role

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.

Responsibilities

• 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.
• Led team to meet project deliverables.
• Absorbs and maintains 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.
• Maintains 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.

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.

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 (FDBN_PNC@fujifilm.com).