Quality Assurance Disposition Manager

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 6 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Quality Assurance (QA) Disposition Manager is responsible for the disposition of both clinical and commercial manufactured products (intermediates and Active Pharmaceutical Ingredients (APIs)) ensuring products are produced and analyzed in accordance with FUJIFILM Biotechnologies procedures and Current Good Manufacturing Practice (CGMP) regulations while making recommendations as needed to release or reject manufactured materials that are manufactured at the site. This role organizes maintains and communicates the status of batch disposition details and partners cross-functionally including with external stakeholders to meet the dynamic needs of the customers programs.

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

Major Accountabilities:

Dispositions manufactured materials ensuring regulatory compliance and patient safety
Determines batch impact and analysis from deviations change controls supplemental test results and facility environmental monitoring and utility conditions as part of contextual review
Performs pre-production activities including review and approval of Master Batch Records (MBR) Batch Material Masters (BMM) in SAP Sampling Plan item specifications and other documents
Coordinates or leads the Material Review Board (MRB) process and participates in customer audits inspections and Product Quality Review (PQR) as needed
Partners cross-functionally regarding technical issues and provides technical expertise related to batch dispositions and deviations
Ensures required information is obtained to successfully complete the review and approval of documents
Partners routinely with management and technical experts to address issues and create workable solutions while maintaining quality standards
Reviews and approves major and Out-of-Specification (OOS) deviations with potential batch impact ensuring the associated investigations are complete clear and written to support Customer and Regulatory acceptance
Provides timely communication and responses to internal and external customers for product related deliverables
Delivers high throughput high quality and right first-time actions while implementing continuous improvement initiatives to support this effort
Performs other duties as assigned

Knowledge Skills or Abilities:

Effective communication both written and oral
Ability to effectively present information to others
Ability to collaborate communicate and provide feedback to others including senior leaders
Demonstrated ability with deviations events and batch disposition documentation
Ability to interact with regulatory agencies outside of and during inspections
Knowledge of SAP TrackWise MasterControl or other GMP software
Ability to identify acceptable materials for GMP use
Knowledge of manufacturing processes equipment facilities and utilities and is well-versed in Quality Systems
Willingness to provide on floor presence to maintain familiarity of programs and to support teams
Must be flexible to support 24/7 manufacturing facility

Minimum Education and Experience Requirements:

Bachelors degree in life science or relevant field with 8 years of applicable industry experience; or
Masters degree in life science or relevant field with 6 years of applicable industry experience; or
Experience in a CGMP Manufacturing Validation and/or Quality role in a Food & Drug Administration (FDA) regulated facility
Previous experience with disposition of biotechnology manufactured Active Pharmaceutical Ingredient (API) or Drug Product (DP)

Preferred Education and Experience Requirements:

Masters degree in life science or relevant field
Experience working in a contract manufacturing organization

Physical Demands:

Ability to discern audible cues.
Ability to inspect or perform a task with 20/20 corrected vision visual acuity including distinguishing color.
Ability to ascend or descend ladders scaffolding ramps etc.
Ability to stand for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 60 minutes.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers.
Ability to operate machinery and/or power tools.
Ability to conduct work that includes moving objects up to 10 pounds.

*LI-onsite

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:

Manager

Position OverviewThe Quality Assurance (QA) Disposition Manager is responsible for the disposition of both clinical and commercial manufactured products (intermediates and Active Pharmaceutical Ingredients (APIs)) ensuring products are produced and analyzed in accordance with FUJIFILM Biotechnologie...