QA Technical Specialist, QA for QC

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Position Overview

The QA Technical Specialist QA for QC is responsible for partnering and helping drive Quality oversight for the direction of all QC Laboratory processes. The QA Technical Specialist QA for QC collaborates with other project teams and with QA departments to align strategies and procedures. The QA Technical Specialist QA for QC continues to ensure that all QC Laboratory systems and processes are operated/maintained in a validated state throughout their lifecycle with a focus on consistent policy administration QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

This role provides essential quality assurance compliance review support for stability drug product release raw material release and Batch disposition. The role is also a primary quality assurance contact for QC deviations. Additionally this role also supports Analytical Development (AD) group on method qualification document reviews and ensuring test method is effective in the system.

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:

Provides QA oversight and support for project deliverables in accordance with the governing processes and procedures for the QC laboratory program
Assesses the impact of data and process modifications and maintains oversight of change management processes.
Provides oversight and approval of laboratory process lifecycle documentation including risk and impact assessments do compliance data review qualification protocols validation plans and validation summary reports and test method implementation
Generates reviews and approves QA documentation procedures and processes for operational readiness objectives and QA support of laboratory operations in cGMP regulated facilities
Ensures that project and operational quality objectives are met within desired timelines
Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
This role and the associated responsibilities develop as the project matures and startup activities evolve into operations
Performs other duties as assigned

Knowledge Skills and Abilities:

Excellent oral and written communications skills and fluency in English
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Understanding of GAMP5 USP<1058> Data Integrity and application of EU Annex 1 21 CFR Parts 11 and 820 as pertains to lab processes.
Understanding of validation of laboratory benchtop and support equipment and methodologies.
Understanding of cell culture upstream processes large scale recovery and/or downstream processes
Knowledge and application of cGMP compliance and other related regulations
Ability to partner with different teams and stakeholders
Strong time management ability to meet tight deadlines to ensure effective prioritization of tasks
Ability to think critically and have superior problem-solving skills
Team based attitude and ability to build relationships and communicate effectively with others.
Occasional opportunity for International and or Domestic travel may be available

Minimum Education and Experience Requirements:

BS/BA in Life Sciences or equivalent with 2 years of experience OR
Masters in Life Sciences or equivalent with 0 year of experience

Preferred Education and Experience Requirements:

1-3 years of experience in GMP Quality Assurance and/or similar role
Experience and working knowledge of Smartsheet Trackwise Veeva and/or Kneat validation software SAP

Physical Demands

Ability to stand for prolonged periods of time.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers
Ability to conduct work that includes moving objects up to 10 lbs
Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions

*#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:

Position OverviewThe QA Technical Specialist QA for QC is responsible for partnering and helping drive Quality oversight for the direction of all QC Laboratory processes. The QA Technical Specialist QA for QC collaborates with other project teams and with QA departments to align strategies and proce...