Senior Quality Assurance Compliance Specialist
5 days ago
Job Summary:
The Senior Quality Assurance Compliance Specialist will support all associated responsibilities in compliance with Fujifilm Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance. The teams are broken up into two core functional groups: One will be overseeing the successful delivery of internal audits and the other one will be overseeing the successful delivery of external audits. You will be assigned to supervise one group or the other but may be asked to provide support to the whole Audit & Inspection group on occasion.
Key Responsibilities:- Leadership: Work collaboratively with site management to instill a Quality Culture by coaching in the application of GMP Principles including the underlying rational of those principles.
- Compliance Delivery: QA support to the organization during internal and regulatory inspections to determine suitability, effectiveness, and compliance with applicable standards and regulations.
- Continuous Improvement: Stay informed about industry trends, regulatory changes, and best practices related to quality assurance and compliance.
- Process Improvement: Proactively identify opportunities for process improvement and recommend strategies to enhance the effectiveness and efficiency of quality systems.
- Training and Development: Provide guidance and support to teams on compliance-related matters, including training and education initiatives.
- Regulatory Compliance: Ensure self-have no overdue training, or site actions. Support other QA teams and other functions in completion of site actions.
- Education: Master's degree preferably in a science-related field with three (3) years industry experience in a GMP / GxP, or a comparable federally regulated environment; OR Bachelor's degree preferably in a science-related field with five (5) years of industry experience in a GMP / GxP, or a comparable federally regulated environment; OR Associate's Degree preferably in a science-related field with seven (7) years of industry experience in a GMP / GxP, or a comparable federally regulated environment; OR High School Diploma or equivalent and nine (9) years of industry experience in a GMP / GxP, or a comparable federally regulated environment.
- Experience: At least two (2) years experience in a supervisory/managerial role. At least three (3) years of auditing experience.
- Skills and Abilities: Excellent written and oral communication skills. Excellent organizational, analytical, data review and report writing skills. Ability to set personal performance goals and provide input to departmental objectives. Ability to multitask and easily prioritize work.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: Experience prolonged standing, some bending, stooping, and stretching. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Must be willing to work flexible hours. Ability to work weekends and off-shift hours, as needed to support manufacturing activities. Must be willing to travel occasionally, as needed. Attendance is mandatory at the College Station, Texas site
Fujifilm Diosynth Biotechnologies is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. If an accommodation to the application process is needed, please email FDBTHR@ or call
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