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 fast-paced environment, is quality-minded, detail oriented, and flexible in work schedule availability to meet the demands of a multi-product clinical and commercial phase cellular therapy company.

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 execution (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 requalification’s 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 FDBC’s 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 decision-making 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

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.