QA Engineer, QC Materials Support

Position Overview

The QA Engineer, Quality Control (QC) Materials Support oversees Quality Assurance during the operational phase. This role and the associated responsibilities develop as the project matures, and startup activities evolve. This role ensures systems and processes in the QC Laboratory are consistently operated and maintained in a validated state throughout their lifecycle. Emphasis is placed on policy administration and providing QA oversight for day-to-day activities, along with addressing and mitigating issues that arise during laboratory operations.

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

Job Description

What You'll Do

 

• Performs SME role within the QA team for onboarding and approving raw materials• Reviews and assesses change controls, deviations, and investigations• Performs SME role within the QA team for the development of documents, processes, and procedures for the QC laboratory program• Provides QA oversight and support of project deliverables in accordance with governing processes, and procedures for the QC laboratory program• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure laboratory systems are first validated, and then maintained in a validated state through site startup and into commercial operations• Provides oversight and approval of laboratory system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of laboratory operations in cGMP regulated facility• Ensures that project and operational quality objectives are met within desired timelines• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections• Performs other duties, as assigned

 

Minimum Requirements:

 

• BS/BA in Life Sciences or Engineering or equivalent with 6+ years of applicable industry experience OR• MS in Life Sciences or Engineering and 4+ years of applicable experience OR• PhD in Life Sciences or Engineering with 2 years of applicable experience• 3+ years of experience in GMP Quality Assurance and/or similar role• Previous experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility• Previous experience in validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT Systems, and methodologies• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11

 

Preferred Requirements:

 

• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl, Veeva, SAP, and/or Kneat validation software• Experience with cell culture, upstream processes, large scale recovery and/or downstream processes• Experience with startup projects or initiatives• Training and/or familiarity with Quality Risk Management principles preferred

 

Physical and Work Environment Requirements: