Quality Assurance Validation Specialist

The QA Validation Specialist will serve as technical subject matter expert for FDBC validation processes including but not limited to facilities utilities and equipment qualification (FUE) manufacturing and laboratory systems and computerized equipment (CSV) and validation software tools. The main responsibility for this role is to provide QA oversight for validation practices at FDBC. The role will also provide QA oversight for validation related topics by supporting QMS processes and deliverables such as SOPs site deviations CAPAs and change control records. The role will work closely with manufacturing quality control quality assurance supply chain engineering and facilities representatives to ensure compliance of cGMP systems with all internal and regulatory quality requirements.

The successful candidate has proficient understanding of CQV industry best practices and regulatory requirements. In addition candidate must have outstanding knowledge of 21CFR Part 11 and EudraLex Volume 4 Annex 11 regulations. excellent communication (written and verbal) skills can thrive in a fastpaced environment is qualityminded detail oriented and flexible in work schedule availability to meet the demands of a multiproduct clinical and commercial phase cellular therapy company.

Join us! FUJIFILM Diosynth Biotechnologies is advancing tomorrows medicine impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers driven by an innate desire to better ourselves our families our workplace our company our community and the world at large.

Reports to: Associate Director QA Validation

Location: Thousand Oaks California

Travel: Up to 10

Primary Responsibilities:

• Participate in development and implementation of validation strategies policies and other documentation for FUE and CSV systems.
• Participate in oversight of Validation Maintenance (Requalification) program (Computerized Systems and FUE) per established procedures.
• Review and approval of validation plans protocols and summary reports for FUE and CSV systems.
• Review and approval of requalifications and periodic reviews for FUE and CSV to ensure validated state is maintained.
• Review and approval of Data Integrity Assurance program deliverables (User Access Review Audit Trail Review Backup Review)
• Review assess and QA ownership for proposed validated system changes via CAPA Change Control and Work Orders to identify requirements necessary to maintain validated status.
• Work with QA and stakeholder departments to investigate system issues and perform root cause analysis and implement solutions.
• Interface with other departments (e.g. IT Engineering Facilities Manufacturing Regulatory Affairs Quality Control and Quality Assurance) to ensure achievement of FDBCs objectives relating to FUE and computerized system validation and associated activities including compliance with all applicable standards and regulations.

Experience Requirements:

• Master of Science (M.Sc. with 2 years of applicable industry experience; or
• Bachelor of Science (B.Sc. with 4 years of applicable industry experience; or
• Associate degree with 6 years of applicable industry experience; or
• High school diploma with 9 of applicable industry experience
• Experience validating facilities utilities and manufacturing and QC instruments and equipment (IT application validation skills a plus) in the pharmaceutical industry.
• Working knowledge and experience with risk management tools.
• Knowledge of relevant regulations and regulatory guidance required to act as a resource for colleagues.
• Independent decisionmaking capability and ability to think conceptually and understand impact of decisions critical.
• Strong conflict resolution and negotiation skills.
• Excellent verbal and written communication skills; good interpersonal skills.
• Must be able to work in controlled manufacturing environments requiring special gowning

Salary and Benefits:

• $104000 to $130000 depending on experience
• Medical Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

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 viaemail 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.

*#LIHybrid

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .