QA Technical Specialist

We are ‘Advancing tomorrow's medicines' and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow's medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

 The QA Technical Specialist  is responsible for batch record review, right first time metrics, deviation review and approval for appropriate root cause analysis and CAPA effectiveness, work cross-functionally and collaboratively supporting batch record and deviation review, support QA product manager for client / project management. The candidate is a compliance leader who is not only adhering to the requirements established by the organization and regulatory bodies but also able to influence others, including peers, cross-functional Members, management, and clients on good manufacturing practices that ensure compliance and product quality.

External US

We are ‘Advancing tomorrow's medicines' and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow's medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

 The QA Technical Specialist is responsible for batch record review, right first time metrics, deviation review and approval for appropriate root cause analysis and CAPA effectiveness, work cross-functionally and collaboratively supporting batch record and deviation review, support QA product manager for client / project management. The candidate is a compliance leader who is not only adhering to the requirements established by the organization and regulatory bodies but also able to influence others, including peers, cross-functional Members, management, and clients on good manufacturing practices that ensure compliance and product quality.

 MAJOR ACTIVITIES AND RESPONSIBILITIES:

• Batch record review, including Quality Support on the Manufacturing floor.
• Deviation review and root cause analysis skills, including CAPA effectiveness
• SAP for product release.
• Deviation and CAPA trending / metrics.
• Electronic systems - TrackWise, SAP, PAS-X, MasterControl, ComplianceWire, Enfor (CMMS).
• Manage decisions within the SOP, standard practice, and regulatory framework.
• Communicate cross-functionally in a positive, inclusive and proactive manner.
• Meet quality and compliance expectations for assigned areas on time, right-first-time, and implement assigned compliance improvements.
• Keep current with required site training and internal compliance requirements for assigned compliance areas. Set, monitor, and report progress on goals and development activities.
• Managing PR On-time metrics, Batch Record review On-time metrics, and Response to Client's Review Feedback timely.
• Support QA product manager for client/project management on a variety of areas, including but not limited to PQR, protocol review, Client's meetings, and Client's compliance-related inquiries.

The ideal candidate will:

• Under limited supervision, meet quality and compliance requirements in all compliance areas. Act as the SME for specific internal compliance function.
• cGMP Capability: Follow SOPs, understand and apply principles of Standard Practices behind the SOPs. Has problem solving skills to identify and solve problems within the SOP and Standard Practice framework. Can lead small QA groups to investigate, recommend improvements to management, and monitor effectiveness of improvements including non-routine issues.
• Proficient in Root Cause Analysis and the use of Quality Tools such as 5 Whys or 6M's.
• Have knowledge and understanding of 21 CFR 210, 211, ICH Q7, and other Codes of Regulations or Guidance that are applicable to biopharmaceutical manufacturing.
• Knowledge of Quality Systems and Production Controls.
• Can make decisions within the SOP and standard practice framework for compliance areas in which they are an SME and can assist others in cross functional peer conflict resolution.
• Communicates cross functionally with peers and QA management in both oral and written form.
• Proficient in Technical Writing, especially from a regulated industry.
• Communicate cross-functionally and collaboratively to manage comment resolution on batch records and deviations.
• Capable of quickly switching gears and taking on multiple assignments under a time-constraint to support milestones and deliverables in a fast-paced environment.
• Demonstrates positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives

Minimum Education Requirements + Years of experience

• BS/BA +6 or MS/PhD +0

Desired Experience

• 8+ years of applicable experience
• Experience with Lean Six Sigma (LSS) methodology
• Experience with biopharmaceutical manufacturing processes

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com 

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 place. 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.