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 Manufacturing Compliance Coordinator will be a member of the Commercial Operations Team, responsible for activities associated with the review of manufacturing batch records and supporting documentation, authoring and ownership of deviations, and continuous improvement around production, compliance and safety.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
Main areas of responsibilities include:
- Leads deviation resolution, working with the subject matter expert and quality teams to ensure deviations are closed on time.
- Generate Quest Data and report metrics and trends. Manage PRs with zero overdue metrics and drive interim impact assessments, when required.
- Responsible for tracking CAPAs to closure.
- Responsible for Periodic Updates of SOPs and Work Instructions.
- Ensuring tier boards are updated with metrics related to production performance, deviations, CAPAs
- Participating in routine practices and team projects relating to TPM, 5S, Lean Six Sigma, Change Control, Safety, Quality, etc.
- Interaction with groups such as Materials Management, EHS, Quality Control and Quality Assurance (QA) on any issues that may arise during the shift or record review.
- Updating batch records, coordinating supplemental sample plans
- Hosts manufacturing Tours for clients, audits, corporate visitors
- Troubleshooting quality defects and making any process changes necessary to eliminate the defects; recording corrective and preventative actions
Preferred Education, Experience and Skills – Minimum Requirements:
- BS/BA (science preferred) and 3+ years of experience in a cGMP (pharmaceutical/manufacturing environment or
- AA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing) environment
Physical Ability: ability to walk, climb stairs, crawl, kneel and lift, frequently throughout the shift, up to 12-hours.
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.