QA Technical Specialist, QA for QC

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, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s 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, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s 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 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job 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
• Must be flexible to support 24/7 manufacturing facility 

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 Exper