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 Quality Assurance group at Fujifilm Diosynth Biotechnologies is seeking a highly motivated individual to join us as a QA Technical Specialist in our Contract Manufacturing site located in Research Triangle Park, NC. The responsibilities related to this position are mainly software validation and QC Instrumentation validation support from a QA perspective.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Meet quality and compliance expectations for assigned areas on time, right-first-time, and implement assigned compliance improvements – 70-95%
- Compliance Area SME – 0-20%
- Keep current with required site training and internal compliance requirements for assigned compliance areas. Set, monitor, and report progress on goals and development activities – 5-10 %
The following knowledge, skills and abilities are required for the successful candidate:
- Experience drafting and reviewing protocols of software validations in a QA compliance capacity
- Experience completing or reviewing a URS for a computerized system or equipment with software
- Experience with change control workflows in a computerized system (i.e. Trackwise)
- Experience with Software Lifecycle
- Previous or current work in a GMP environment
The ideal candidate will:
- Under limited supervision, meet quality and compliance requirements in Multiple Compliance areas.
- cGMP Capability: Follow SOPs, understand and apply principles of Std Practices behind the SOPs
- Act as the SME for Specific Internal Compliance function with limited supervision
- Has problem solving skills to identify and solve problems within the SOP and Std Practice framework. Can lead small QA groups to investigate, recommend improvements to management, and monitor effectiveness of improvements including non-routine issues
- Can make decisions within the SOP and std 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
- Demonstrates positive inclusive behaviors, consistently promotes positive team attitude, and supports business objectives.
- Be experienced with eCompliance
- 21 CFR Part 11
- Software Validation Experience
Education + Years of Experience
- BS/BA +6 or MS/PhD +0
- Software validation experience
- Understanding of software life cycle principles
- GMP experience
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.
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.