Quality control assistant Jobs in Durham, NC

Position Overview

The Sr. Director Quality Control provides strategic technical and operational leadership to the site Quality Control Laboratories. This role proactively leads implementation of GMP industry standard methodologies across the Quality Control Laboratories. The Sr. Director Quality Control plays a major role in the site operations while remaining adaptable to the changing needs for new clients and programs and is accountable for the sustained and ever improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays most innovative biopharmaceutical companies FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site we thrive on collaboration creativity and purpose. Whether your expertise lies in research manufacturing or production youll find a home here where your efforts directly improve patients lives. Together lets shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP) North Carolina our site is at the heart of a booming biotech hub surrounded by top universities vibrant communities and various outdoor opportunities.

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 : Description

What Youll Do :

• Develops and implements the strategy and roadmap for Quality Control at the Morrisville site with the overall Global Quality Strategy generated at a global collaboration
• Builds develops and leads the QC team with intention providing clear priorities feedback and career development opportunities in alignment with the departments objectives
• Leads the growth and expansion of the QC team at the site including regional accountabilities for intra-company testing to support the Holly Springs site and additional sites
• Provides strategic decision-making; prioritizes deliverables to meet site and compliance objectives
• Oversees all QC operations including In Process Testing Bulk Release and Stability Testing Microbiological Testing the Environmental and Utility Monitoring program
• Supports and participates in client visits audits and regulatory agency inspections
• Ensures budgets timelines schedules and performance requirements are established and met
• Assures all areas of responsibility conform to cGMP and other appropriate regulatory
• Interacts and meets regularly with cross-functional leaders on matters concerning their functional areas groups or clients
• Assures that all areas of responsibility are cGMP compliant and audit-ready
• Oversees the development and implementation of standards methods and procedures for testing and evaluating the quality and safety of products
• Manages technology transfers and method improvements needed to assure reliable robust fit for purpose and cGMP compliant methods available for the laboratories
• 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 all other duties as assigned

Minimum Requirements :

Preferred Qualifications :

Knowledge Skills or Abilities :

Working & Physical Conditions

Ability to inspect or perform a task with 20 / 20 corrected vision visual acuity including distinguishing color.

Ability to discern audible cues.

Ability to sit for prolonged periods of time up to 60 minutes.

Ability to conduct activities using repetitive motions that include wrists hands or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

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.

EEO Information

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.

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 ().

Required Experience :

Exec

Key Skills

Computer,IT Audit,CAD CAM,ABAP,Exterior Designing,HR Operations

Employment Type : Full Time

Department / Functional Area : Quality Control

Experience : years

Vacancy : 1