Quality Assurance-Compliance Specialist II-Audit and Inspection

The Quality Assurance Compliance Specialist II Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FDB and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what FUJIFILM Diosynth Biotechnologies call Genki.

College Station Texas may be a small university town but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of smalltown life and the convenience of living close to the vibrant pulse of big cities. Eightyseven percent of Texas population lives within a 180mile radius so we are in the center of it all in Texas. And our site is nestled in the hub of innovation representing a source of pride for the area.

Essential Functions:

• 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.
• Mentor peers towards achieving organizational and individual goals.
• Compliance Delivery
• QA support to the organization during client audits and regulatory inspections to determine suitability effectiveness and compliance with applicable standards and regulations.
• Displays critical thinking expertise with the ability to define and implement a strategic approach to audit based on compliance and business knowledge.
• New Business Growth
• Support client due diligence and Quality audits as well as regulatory inspections.
• Work with Quality management to ensure quality systems support cGMP manufacturing of preclinical to commercial products.
• Compliance
• Ensure selfhave no overdue training or site actions. Support other QA teams and other functions in completion of site actions.
• Provide cGMP guidance to other functions such as Manufacturing Facilities and QC Warehouse and Validations.
• Support Site Readiness Preparation for Regulatory Inspections.
• Staying aware and up to date with agency regulations guidance documents and industry best practices to ensure Fujifilm Texas site is held to current standards
• Execute audit strategy and lead process audits
• Monitor quality in support of maintaining inspection readiness
• Provides support during regulatory inspections or customer audits as requested by the company before during and/or after the event.
• Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Ensure audit and inspection reports are responded on time.
• Works on complex problems in which analysis of situations or data requires indepth evaluation of various factors from many sources. Is adept at interpreting GMP regulations in the resolution of problems and in the design of systems processes or procedures.
• Ability to effectively plan organize and execute work that ensures deliverables are consistently met
• All other duties as assigned.

Required Skills & 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.

Working Conditions & Physical Requirements:

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.
• Ability to sit for long periods to work on a computer.
• Potential for exposure to chemicals gases fumes odors dusts and other hazardous materials.
• Ability to wear personal protective equipment including but not limited to safety glasses lab coat gloves specialized clothing including laboratory scrubs (pants and shirt) cleanroom (ISO 8 to ISO 5 gowning material and appropriate shoes required in most areas associated with this position.
• Lifting up to 25 pounds on occasion.
• Use handeye 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 offshift hours as needed to support manufacturing activities.
• Must be willing to travel occasionally as needed.
• Attendance is mandatory.

Qualifications:

• High school diploma or GED and six 6 years of experience in a regulated industry including two 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• Associate degree in a related science concentration with 4 years of experience in a regulated industry including 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• Bachelors degree in a related science concentration with 2 years of experience of cGMP supporting pharmaceutical or biotechnology products; OR
• Masters degree in a related science concentration with 1 years of experience of cGMP supporting pharmaceutical or biotechnology products.

Preferred Qualifications:

• Certified Quality Auditor
• Degree in Biology Chemistry or Engineering

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 or.