Quality assurance manager jobs in College Station, TX

The Quality Assurance (QA) Supervisor will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Reports to Senior Manager, Quality Assurance Work Location College Station, TX Essential Functions: * Supervise and provide direction to direct reports. * Serve as TrackWise Administrator. * Monitor and support site and global quality policies and procedures to ensure GMP compliance. * Work with QA management to design and implement quality assurance training programs for staff development. * Provide cGMP guidance to operations, QC and QA. * Lead client audits and regulatory inspections. * Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions. * Develop, motivate and lead direct reports towards achieving organizational and individual goals. * Conduct periodic staff meetings. * Review and/or approve basic and technical documentation to include, but not limited to: * Standard Operating Procedures * Batch Production Records (completed and approval) * Commissioning, qualification and validation protocols and reports * Deviation Reports * Corrective Action/Preventive Action Plans * Technical data review and approval * QC data review and approval * Drug Substance/Product Reports * Manage Internal Quality audit functions to include, but not limited to: * Audit of lab notebooks * Audit of equipment logbooks * Review of vendor, supplier, contract laboratory audit questionnaires * Lead vendor, supplier, contract laboratory * Identify process and Quality System improvement opportunities. * Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. * Assist with compliance related functions. * Work as a team member; be cooperative with all departments and staff to meet company objectives. * 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. * Develop staff to maximize contributions to the team and the company. * Ability to multitask and easily prioritize work. * Ability to work independently with little supervision. * Proficient in Microsoft Excel, Word and PowerPoint. * All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. * Role model for company core values of trust, delighting our customers, and Gemba. 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 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. Qualifications: * Master's degree in a science-related field with 3+ years of related experience; OR, * Bachelor's degree in a science-related field with 5+ years of related experience. * 2+ years of prior supervisory or lead experience. * 2+ years of cGMP experience. Preferred Qualifications: * Certified Quality Auditor * Degree in Biology, Chemistry 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

The Quality Assurance (QA) Supervisor will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to Senior Manager, Quality Assurance Work Location College Station, TX Essential Functions: Supervise and provide direction to direct reports. Serve as TrackWise Administrator. Monitor and support site and global quality policies and procedures to ensure GMP compliance. Work with QA management to design and implement quality assurance training programs for staff development. Provide cGMP guidance to operations, QC and QA. Lead client audits and regulatory inspections. Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions. Develop, motivate and lead direct reports towards achieving organizational and individual goals. Conduct periodic staff meetings. Review and/or approve basic and technical documentation to include, but not limited to: Standard Operating Procedures Batch Production Records (completed and approval) Commissioning, qualification and validation protocols and reports Deviation Reports Corrective Action/Preventive Action Plans Technical data review and approval QC data review and approval Drug Substance/Product Reports Manage Internal Quality audit functions to include, but not limited to: Audit of lab notebooks Audit of equipment logbooks Review of vendor, supplier, contract laboratory audit questionnaires Lead vendor, supplier, contract laboratory Identify process and Quality System improvement opportunities. Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Assist with compliance related functions. Work as a team member; be cooperative with all departments and staff to meet company objectives. 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. Develop staff to maximize contributions to the team and the company. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Proficient in Microsoft Excel, Word and PowerPoint. All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. Role model for company core values of trust, delighting our customers, and Gemba. 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 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. Qualifications: Master's degree in a science-related field with 3+ years of related experience; OR, Bachelor's degree in a science-related field with 5+ years of related experience. 2+ years of prior supervisory or lead experience. 2+ years of cGMP experience. Preferred Qualifications: Certified Quality Auditor Degree in Biology, Chemistry 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

The Quality Assurance (QA) Supervisor will be responsible for the overall performance of the QA group. The supervisor will handle all associated responsibilities in compliance with FUJIFILM quality policies and site SOPs to ensure regulatory compliance. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to Senior Manager, Quality Assurance Work Location College Station, TX Essential Functions: Supervise and provide direction to direct reports. Serve as TrackWise Administrator. Monitor and support site and global quality policies and procedures to ensure GMP compliance. Work with QA management to design and implement quality assurance training programs for staff development. Provide cGMP guidance to operations, QC and QA. Lead client audits and regulatory inspections. Utilize investigative techniques to determine root causes of deviations and proper corrective and preventative actions. Develop, motivate and lead direct reports towards achieving organizational and individual goals. Conduct periodic staff meetings. Review and/or approve basic and technical documentation to include, but not limited to: Standard Operating Procedures Batch Production Records (completed and approval) Commissioning, qualification and validation protocols and reports Deviation Reports Corrective Action/Preventive Action Plans Technical data review and approval QC data review and approval Drug Substance/Product Reports Manage Internal Quality audit functions to include, but not limited to: Audit of lab notebooks Audit of equipment logbooks Review of vendor, supplier, contract laboratory audit questionnaires Lead vendor, supplier, contract laboratory Identify process and Quality System improvement opportunities. Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance. Assist with compliance related functions. Work as a team member; be cooperative with all departments and staff to meet company objectives. 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. Develop staff to maximize contributions to the team and the company. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Proficient in Microsoft Excel, Word and PowerPoint. All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. Role model for company core values of trust, delighting our customers, and Gemba. 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 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. Qualifications: Master's degree in a science-related field with 3+ years of related experience; OR, Bachelor's degree in a science-related field with 5+ years of related experience. 2+ years of prior supervisory or lead experience. 2+ years of cGMP experience. Preferred Qualifications: Certified Quality Auditor Degree in Biology, Chemistry 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

Founded in 1898 and headquartered in Chicago, IL, GATX Corporation (NYSE: GATX) is an industry leader with 125+ years of success-success that is powered by our people. At GATX, we hire the best and offer our employees a dynamic, energetic, collaborative environment to enable them to make an impact from day one. Enjoy the perks and benefits of a global company with the close-knit culture and community of a much smaller one. In the same way we strive to empower our customers to propel the world forward, we are dedicated to providing our people with the tools and resources they need to move forward in their careers. In this role, you will lead and direct facility operations at the Hearne Service Center. This position will support the management and execution of the quality program and its components to ensure compliance to regulatory, GATX and customer requirements. This position will also support research and analysis of quality and maintenance related issues and implementation of quality improvements at the facility. Responsibilities * Technical Resource * Function as a technical resource for GATX personnel throughout the facility * Participate on cross-functional teams to evaluate, define, and improve our processes to ensure alignment and achievement of GATX initiatives * Apply the GATX Quality program requirements to in-process and/or outbound repairs and support the development of others' quality knowledge * Training * Perform Quality Training (qualifications, document updates, etc.) * Maintain the Quality training database, training records and employee certifications * Act as Weld Facilitator for the facility, as needed * Gauge Management * Manage gauge calibration records * Perform calibrations, as needed * Provide oversight to ensure calibration requirements are known and adhered to * Auditing * Serve as liaison for external audits * Perform internal audits to confirm compliance with GATX, regulatory and customer requirements * Develop reports and supporting details presenting audit results * Work with applicable individuals to devise and implement actions to correct deficiencies and follow up on those actions to ensure effectiveness Interaction: * The individual in this position will interact with all levels of personnel throughout both the facility and the organization. The primary focus of this position is serving as a technical resource to ensure railcar repairs and all related activities are in compliance with documented repair guidelines prepared by regulatory agencies, railcar engineers and customers. Qualifications Education and/or Experience: * High school diploma or equivalent required * 3 - 5 years of relevant work experience * General Inspector Qualification * VT certification or the ability to gain this certification * Knowledge and experience in applying structured problem-solving practices (e.g. 5 Whys) * Advanced computer skills, including experience or the ability to be proficient with the following systems: * MS Office Suite (Word, Excel, and PowerPoint) * LCA * MMS * Shop Portal * ECM * MIS * SEM * SharePoint * Railinc * ETQ * Power BI Key Competencies: * Strong Core Values (integrity, respect, ownership, teamwork, openness, creativity, positive attitude) * Ability to read and interpret technical documents such as QA Documents, IO instructions, FM instructions, work orders, drawings, AAR Field Manual and AAR MSRPs * Communication, both verbal and written Other: * Must be able to work in extreme temperature environments * Must be able to lift up to 50 pounds * Must be able to climb ladders and perform work at elevated heights * Must be able to walk for extended periods of time * Must be able to sit/work in front of a computer for extended periods of time * Minimal travel may be required within the US and Canada Posting Duration This posting will remain open until the role is filled. As of the post date, the salary range for this position is: Min USD $78,000.00/Yr. Max USD $86,000.00/Yr. This role may be eligible to participate in the Company's short-term incentive plan, the details of which will be provided to the applicant upon hire. This range is a reasonable estimate and takes into account several factors that are considered in making compensation decisions, including, but not limited to, geographic location, skill set, experience, education, training, internal equity, and other business needs. Responsibilities - Technical Resource - Function as a technical resource for GATX personnel throughout the facility - Participate on cross-functional teams to evaluate, define, and improve our processes to ensure alignment and achievement of GATX initiatives - Apply the GATX Quality program requirements to in-process and/or outbound repairs and support the development of others' quality knowledge - Training - Perform Quality Training (qualifications, document updates, etc.) - Maintain the Quality training database, training records and employee certifications - Act as Weld Facilitator for the facility, as needed - Gauge Management - Manage gauge calibration records - Perform calibrations, as needed - Provide oversight to ensure calibration requirements are known and adhered to - Auditing - Serve as liaison for external audits - Perform internal audits to confirm compliance with GATX, regulatory and customer requirements - Develop reports and supporting details presenting audit results - Work with applicable individuals to devise and implement actions to correct deficiencies and follow up on those actions to ensure effectiveness Interaction: - The individual in this position will interact with all levels of personnel throughout both the facility and the organization. The primary focus of this position is serving as a technical resource to ensure railcar repairs and all related activities are in compliance with documented repair guidelines prepared by regulatory agencies, railcar engineers and customers.

SUMMARY: The QC Manager is responsible for overseeing all aspects of quality assurance and quality control within the fabrication shop. This role ensures that products, processes, and services consistently meet customer, regulatory, and ISO 9001 requirements. The QC Manager will lead inspections, audits, and continuous improvement initiatives to maintain compliance and drive product excellence. RESPONSIBILITIES * Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 9001 standards. * Conduct internal audits, manage external audits, and ensure compliance with industry certifications (e.g., ISO, AIS, AWS, customer-specific requirements). * Lead root cause analysis and corrective/preventive action (CAPA) programs. * Oversee inspection and testing of incoming materials, in-process components, and final products. * Verify conformance to blueprints, specifications, weld codes, and project requirements. * Ensure calibration and maintenance of measurement tools and testing equipment. * Maintain accurate inspection reports, material certifications, weld records, and non- conformance reports. * Prepare quality documentation for customer submittals and project closeouts. * Track and report on key quality performance metrics (e.g., defect rate, NCRs, rework percentage). * Manage and mentor QC inspectors, welding inspectors, and other quality staff. * Provide training to shop employees on quality standards, ISO 9001 requirements, and best practices. * Foster a culture of quality, accountability, and continuous improvement. * Work directly with customers and third-party inspectors during shop inspections and project milestones. * Evaluate vendor quality performance and work with supply chain to ensure incoming materials meet standards. * Manage subcontractor quality compliance for outsourced processes (e.g., coatings, NDE). QUALIFICATIONS * 5+ years of experience in quality management within steel fabrication/ manufacturing. * Strong knowledge of ISO 9001 requirements and experience in implementing or maintaining a QMS. * Familiarity with welding codes (AWS, ASME) and inspection methods (visual, dimensional, NDE). * Strong leadership, communication, and problem-solving skills. * Proficient in reading technical drawings, specifications, and standards. * Certified Quality Manager or Welding Inspector (CWI) preferred * Performance Metrics (KPls) * ISO 9001 audit results and compliance status JOB CODE: 1000302

Job DescriptionDescriptionWho We Are: We're building a better way to donate plasma - one that's fast, friendly, and powered by smart technology - our donor app makes booking and earning easy for donors, and our team makes every visit feel welcoming and personal. We've grown from 2 to 30+ locations in under 3 years, and we're just getting started. If you want to grow your career with a high-energy team, this is a great opportunity. What You'll do: As the Center Quality Assurance Supervisor, you'll own the regulatory and compliance program at the Donor Center, ensuring it operates at the highest standards of compliance, accuracy, and safety. You will be a key part of our culture of quality, holding the team accountable while creating a positive environment for the team and our donors. You will have a unique opportunity to be part of a high-growth organization, one that is changing rapidly and creating new opportunities for our high-performing team members. Compensation: Up to $70K ($50K - $55K base + up to 25% monthly bonus) + benefits Travel: 8 weeks of paid training with travel and accommodations provided Key Responsibilities Lead quality programs, including overseeing inspections, audits, and corrective action plans. Keep the center audit-ready by maintaining compliance with industry, government, and company regulations at all times. Provide independent oversight - maintain quality checks and documentation separate from daily operations to ensure objectivity. Support center leadership - work closely with the Center Director to maintain safety and operational excellence. Improve processes - track trends, analyze data, and implement plans to increase efficiency and reduce risk. Oversee training and knowledge - ensure staff are trained and compliant with new policies and procedures. Required Qualifications 3+ years of experience in a regulated or process-driven environment (e.g., manufacturing, clinical, or business settings) High school diploma, GED equivalent, or higher education Ability to lift 50 lbs., sit or stand for extended periods, and enter cold environments (-40°ree;C) for short periods Ability to work day and evening hours, weekends, holidays and extended shifts as needed. Who You Are A Detail -Oriented Problem Solver - You take ownership. You're excited to get in the weeds, know how to creatively prioritize and solve a long, ambiguous, and evolving task list, are trustworthy and outcomes oriented An Empathetic Communicator - You know how to adapt your communication style to meet different audiences (staff with different styles, donors, Ops leadership); you have strong conflict resolution skills, are even-keeled under pressure, and know how to motivate and inspire others A Development-Minded Employee - You are self-aware and curious, have integrity, and have a track record of steep learning curves A Data-Driven Decision Maker - You are metrics driven, have strong logical reasoning and decision-making skills, aren't distracted by one-offs or edge cases Who You Are Not Someone who isn't excited to get their hands dirty - while you are hired for a role, our operations are often unpredictable, and we need people willing to jump in where they're needed. Someone who doesn't thrive in an environment of continuous change - we are in a hypergrowth stage, which is unique for this industry. We need people who are excited to be with us on this rollercoaster. Someone who wants to clock in and clock out. We are looking for team players who care about the impact their centers have on their communities and the plasma-based medicine, which takes a true ownership mentality and often extra hours. Why Join Parachute? Competitive compensation with bonus potential Medical, Dental, and Vision insurance Paid time off Company paid holidays Career growth opportunities

The Quality Engineer oversees all quality-related activities undertaken to support manufactured products at DTTP, the Products we procure from other sister plants, and the products and accessories we procure from third-party vendors. Responsible for the continuous improvement of the organization's product quality and procedure adherence to ensure quality consistency. Reviews quality standards, tolerances, and engineering changes. Evaluates engineering changes for existing products, outsourced parts, processes and subassemblies, and new products. Analyzes engineering specifications and manufacturing processes for newly introduced products, Develops test plans and quality testing equipment. Monitors periodic warranty reports and drives improvement initiatives. Investigates and analyzes complex quality problems, recommends solutions, and ensures corrections are made. Position Responsibilities may include: Be the advocate for the manufacturing operations and end customers, ensuring all the new products are launched at a better-quality level than the products we currently produce. Through a comprehensive set of established metrics, the Quality Engineer tracks and communicates the current state of product launches and the performance of the products that were launched. Drive a culture of continuous improvement and assuring product quality by virtue of standards adherence. In coordination with others, Tech Services, Quality Control, Reliability, Warranty Analytics, and Supplier Quality, oversee and drive the Corrective and Preventive Actions related to quality issues, directly affecting DTTP operations.  o This applies to new products that are manufactured at DTTP and products manufactured at other Daikin sister plants by taking the lead with multidisciplinary teams to drive corresponding efforts to execute corrections to product designs/standards, supplier issues, and even internal manufacturing processes. o Communicate internally regarding current quality problems such as 8D's- problem description, status, root cause analysis, and resolution timetable. Create and take the leadership role to complete Development Quality Improvement and Warranty Monitoring reporting activities for all new product launches. Lead and orchestrate all New Product Launch related efforts to minimize the impact on manufacturing operations.  Provide support to production and ensure system adherence Ensure that product design, supplier, reliability, and component changes have been fully verified and validated through the design engineering test processes and reliability test processes. Coordinate with cross-functional teams to resolve quality issues. Ensure product design, supplier, and component changes are validated. Conduct root cause analysis and implement corrective actions for moderate issues. Manage small projects with some guidance from managers and other engineers. Coordinate effectively with the Design, Procurement, Supplier Quality Assurance, and Reliability Departments to ensure that supplier changes and internal changes are fully qualified before implementation.  Proficient use of basic quality tools,control plans and SPC. Solid understanding of manufacturing defects and quality issues. Basic root cause analysis and corrective action implementation Ability to convert data into actionable information. Ensure that the Quality Policy and the Daikin Core Values are: 1) understood at all levels in his/her department, and 2) used as a guide to all decision-making in his/her department.  Ensure smooth operation of the Development Quality Department - Set clear expectations, reasonable work assignments, fair scheduling, equal job opportunity but effective hiring, firm discipline, high-performance team management, transparent budgeting/spending, and environmentally friendly practices.  Intermediate project management skills. Identify potential risks Implement basic quality assurance practices to ensure project deliverables meet required standards. Lead data collection and analysis for quality improvement projects. Implement basic quality tools and statistical process control (SPC). Perform additional projects/duties to support ongoing business needs. Nature & Scope: Applies practical knowledge of job area typically obtained through advanced education and work experience. Encouraged to seek continuous improvements. Performs a range of mainly straightforward assignments. Works independently with general supervision. Problems faced are difficult but not typically complex. Knowledge & Skills: Good interpersonal skills and leadership qualities. Capable of managing multiple projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Capable of managing projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Six Sigma and/or Quality Engineering certification will be a plus. Working knowledge of HVAC system designs and standards. Understanding of common manufacturing defects and quality issues in HVAC systems or similar industry Ability to convert data into actionable information by utilizing statistical methods to characterize and analyze data to find potential solutions to problems and facilitate decision-making. Familiar with data analysis tools, such as Minitab, Excel (pivot tables), Tableau, MAPICS, etc. Strong problem-solving skills to effectively identify root causes of quality problems and drive multidisciplinary teams to find and execute solutions by utilizing DMAIC, Design of Experiment, 6 sigma methods, FMEA, 8 Disciplines, lean methods, etc. Solid skills in Engineering standards/drawing interpretation. Good communication skills, including presentation development, meeting organization/facilitation, clear conveyance & transmission of information through written & verbal form. Good knowledge in quality management systems with good technical background (HVAC preference), to drive supplier quality improvements Ability to apply good judgment, strong work ethic, and integrity on the job. Competencies: Experience: 2- 4 years of experience in Quality Engineering. Education/Certification: Bachelor's degree in Engineering (Mechanical, Industrial, or related field). Six Sigma Green Belt or equivalent preferred. People Management: No Physical Requirements / Work Environment: Must be able to perform essential responsibilities with or without reasonable accommodations Reports To: Quality Manager, Quality Director The Company provides equal employment opportunity to all employees and applicants regardless of a person's race, color, religion (including religious dress or grooming practices), creed, national origin (including language use restrictions), citizenship, uniform service member or veteran status, ancestry, disability, physical or mental disability (including HIV/AIDS), medical condition (including cancer and genetic characteristics), genetic information, request for protected leave, marital status, sex, pregnancy, age (over 40), sexual orientation, gender, gender identity or expression, political affiliation, or any other characteristic protected by law. The Company will comply with all federal and state regulations and statutes about individuals with disabilities.

Job Description The Quality Engineer oversees all quality-related activities undertaken to support manufactured products at DTTP, the Products we procure from other sister plants, and the products and accessories we procure from third-party vendors. Responsible for the continuous improvement of the organization's product quality and procedure adherence to ensure quality consistency. Reviews quality standards, tolerances, and engineering changes. Evaluates engineering changes for existing products, outsourced parts, processes and subassemblies, and new products. Analyzes engineering specifications and manufacturing processes for newly introduced products, Develops test plans and quality testing equipment. Monitors periodic warranty reports and drives improvement initiatives. Investigates and analyzes complex quality problems, recommends solutions, and ensures corrections are made. Position Responsibilities may include: Be the advocate for the manufacturing operations and end customers, ensuring all the new products are launched at a better-quality level than the products we currently produce. Through a comprehensive set of established metrics, the Quality Engineer tracks and communicates the current state of product launches and the performance of the products that were launched. Drive a culture of continuous improvement and assuring product quality by virtue of standards adherence. In coordination with others, Tech Services, Quality Control, Reliability, Warranty Analytics, and Supplier Quality, oversee and drive the Corrective and Preventive Actions related to quality issues, directly affecting DTTP operations. o This applies to new products that are manufactured at DTTP and products manufactured at other Daikin sister plants by taking the lead with multidisciplinary teams to drive corresponding efforts to execute corrections to product designs/standards, supplier issues, and even internal manufacturing processes. o Communicate internally regarding current quality problems such as 8D's- problem description, status, root cause analysis, and resolution timetable. Create and take the leadership role to complete Development Quality Improvement and Warranty Monitoring reporting activities for all new product launches. Lead and orchestrate all New Product Launch related efforts to minimize the impact on manufacturing operations. Provide support to production and ensure system adherence Ensure that product design, supplier, reliability, and component changes have been fully verified and validated through the design engineering test processes and reliability test processes. Coordinate with cross-functional teams to resolve quality issues. Ensure product design, supplier, and component changes are validated. Conduct root cause analysis and implement corrective actions for moderate issues. Manage small projects with some guidance from managers and other engineers. Coordinate effectively with the Design, Procurement, Supplier Quality Assurance, and Reliability Departments to ensure that supplier changes and internal changes are fully qualified after implementation. Proficient use of basic quality tools,control plans and SPC. Solid understanding of manufacturing defects and quality issues. Basic root cause analysis and corrective action implementation Ability to convert data into actionable information. Ensure that the Quality Policy and the Daikin Core Values are: 1) understood at all levels in his/her department, and 2) used as a guide to all decision-making in his/her department. Ensure smooth operation of the Development Quality Department - Set clear expectations, reasonable work assignments, fair scheduling, equal job opportunity but effective hiring, firm discipline, high-performance team management, transparent budgeting/spending, and environmentally friendly practices. Intermediate project management skills. Identify potential risks Implement basic quality assurance practices to ensure project deliverables meet required standards. Lead data collection and analysis for quality improvement projects. Implement basic quality tools and statistical process control (SPC). Perform additional projects/duties to support ongoing business needs. Nature & Scope: Applies practical knowledge of job area typically obtained through advanced education and work experience. Encouraged to seek continuous improvements. Performs a range of mainly straightforward assignments. Works independently with general supervision. Problems faced are difficult but not typically complex. Knowledge & Skills: Good interpersonal skills and leadership qualities. Capable of managing multiple projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Capable of managing projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Six Sigma and/or Quality Engineering certification will be a plus. Working knowledge of HVAC system designs and standards. Understanding of common manufacturing defects and quality issues in HVAC systems or similar industry Ability to convert data into actionable information by utilizing statistical methods to characterize and analyze data to find potential solutions to problems and facilitate decision-making. Familiar with data analysis tools, such as Minitab, Excel (pivot tables), Tableau, MAPICS, etc. Strong problem-solving skills to effectively identify root causes of quality problems and drive multidisciplinary teams to find and execute solutions by utilizing DMAIC, Design of Experiment, 6 sigma methods, FMEA, 8 Disciplines, lean methods, etc. Solid skills in Engineering standards/drawing interpretation. Good communication skills, including presentation development, meeting organization/facilitation, clear conveyance & transmission of information through written & verbal form. Good knowledge in quality management systems with good technical background (HVAC preference), to drive supplier quality improvements Ability to apply good judgment, strong work ethic, and integrity on the job. Competencies: Experience: 2- 4 years of experience in Quality Engineering. Education/Certification: Bachelor's degree in Engineering (Mechanical, Industrial, or related field). Six Sigma Green Belt or equivalent preferred. People Management: No Physical Requirements / Work Environment: Must be able to perform essential responsibilities with or without reasonable accommodations Reports To: Quality Manager, Quality Director The Company provides equal employment opportunity to all employees and applicants regardless of a person's race, color, religion (including religious dress or grooming practices), creed, national origin (including language use restrictions), citizenship, uniform service member or veteran status, ancestry, disability, physical or mental disability (including HIV/AIDS), medical condition (including cancer and genetic characteristics), genetic information, request for protected leave, marital status, sex, pregnancy, age (over 40), sexual orientation, gender, gender identity or expression, political affiliation, or any other characteristic protected by law. The Company will comply with all federal and state regulations and statutes about individuals with disabilities.

The Quality Assurance (QA) Manager of Audit & Inspection will be responsible for the hosting and managing client audits, regulatory inspections, internal audits, and supplier assurance. The Manager will handle all associated responsibilities in compliance with Fujifilm quality policies and site SOPs to ensure regulatory compliance. Reports to Director, Quality Assurance Compliance Work Location College Station, TX Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Essential Functions: Leadership Mentors and provides direction to the QA compliance organization to ensure organization is complying with local and global quality standards, regulatory requirements and partner commitments. Develop, motivate and lead direct reports towards achieving organizational and individual goals. Work collaboratively with management of other site functions to instill a ‘Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. Compliance Delivery QA leadership and support to the organization in conducting audits and hosting audits/inspections. New Business Growth Support client due diligence and Quality audits as well as regulatory inspections. Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products. Compliance Responsible for managing and reporting all aspects of a fully functional GxP-QA audit program for clinical and commercial CDMO. Manage the external and internal Audit Programs to assure that all are in an acceptable state of compliance. Responsible for audit preparations, conducting internal audits, hosting client audits, developing and coordinating responses to client audits, regulatory inspections, and to ensure supporting documentation, tracking and verification of CAPA commitment implementation. Provide and manage metrics and the implementation tracking of corrective and preventive actions in follow-up to audits and inspections. Support Global Supplier Assurance - work with the global team to participate and represent Texas Site in supporting joint audits. All other duties as assigned. Required Skills & Abilities: Master's degree with 5+ years' industry experience in a GMP/GxP, or a comparable federally regulated environment. Bachelor's degree 7+ years' industry experience in a GMP/GxP, or a comparable federally regulated environment. 4+ years of experience in supervisory or managerial role. Experience with direct dealings with the FDA, MHRA and other European or world-wide regulatory agencies. Certified Quality Auditor preferred. Degree in Biology, Chemistry or Engineering preferred. 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. Develop staff to maximize contributions to the team and the company. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Proficient in Microsoft Excel, Word and PowerPoint. All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. 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 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. 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FUJIFILM Biotechnologies, Texas. The Quality Assurance (QA) Specialist III for Data Integrity will be responsible for the day to day running of the FUJIFILM Biotechnologies, Texas Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks. Reports to Senior Director, QA Compliance Work Location College Station, TX Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Primary Responsibilities: * Work collaboratively with all levels of the FUJIFILM Biotechnologies, Texas site to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. * Act as an ambassador for FUJIFILM Biotechnologies Quality Culture. * Deputize fronting Data Integrity in customer and regulatory audits (as required). * Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products. * Work as a change agent to compliantly improve existing or introduce new ways of working. * Strong experience with GMP, manufacturing processes, quality and regulatory requirements. * Ensure smooth operation of the FUJIFILM Biotechnologies, Texas Data Integrity program highlighting any issues in a timely manner. * Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed. * Provide coaching and training for staff in Data Integrity Principles. * Engage in global FUJIFILM Biotechnologies projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems. * Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up. * Review pre-purchase of systems and analyze to ensure Data Integrity Compliance. * Draft FMEAs and lead stakeholder meetings. * Raise and manage change controls and CAPAs, and drive mitigation and remediation. * All other duties as assigned. Qualifications: * Bachelor's degree with 3+ years of experience in Pharmaceutical, Biotechnology or other regulated Industry. * Master's Degree with 1+ years experience in Pharmaceutical, Biotechnology or other regulated Industry. * Involvement in Data Integrity projects during previous roles. * Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.Develop staff to maximize contributions to the team and the company. * Ability to multitask and easily prioritize work. * Ability to work independently with little supervision. * Proficient in Microsoft Excel, Word and PowerPoint. * All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. * Ability to collaborate effectively with stakeholders from across the business, at all levels. * Excellent written and oral communication skills. * Excellent organizational, analytical, data review and report writing skills. * Motivated cross functional worker. * Ability to set and achieve personal performance goals. * Provide input to departmental objectives. 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 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. 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FUJIFILM Biotechnologies, Texas. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FUJIFILM Biotechnologies, Texas Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks. Reports to Senior Director, QA Compliance Work Location College Station, TX Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Primary Responsibilities: Work collaboratively with all levels of the FUJIFILM Biotechnologies, Texas site to instill a ‘Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. Act as an ambassador for FUJIFILM Biotechnologies, Texas Quality Culture. Deputize fronting Data Integrity in customer and regulatory audits (as required). Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products. Work as a change agent to compliantly improve existing or introduce new ways of working. Strong experience with GMP, manufacturing processes, quality and regulatory requirements. Ensure smooth operation of the FUJIFILM Biotechnoloigies, Texas Data Integrity program highlighting any issues in a timely manner. Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed. Provide coaching and training for staff in Data Integrity Principles. Engage in global FUJIFILM Biotechnologies projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems. Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up. Review pre-purchase of systems and analyze to ensure Data Integrity Compliance. Draft FMEAs and lead stakeholder meetings. Raise and manage change controls and CAPAs, and drive mitigation and remediation. All other duties as assigned. Qualifications: Bachelor's degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products or 1 year experience with FUJIFILM Biotechnologies with a related role; OR, Associate's 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; High School or equivalent and 6+ years of experience of cGMP supporting pharmaceutical or biotechnology products. Involvement in Data Integrity projects during previous roles preferred. Ability to collaborate effectively with stakeholders from across the business, at all levels. Excellent written and oral communication skills. Excellent organizational, analytical, data review and report writing skills. Motivated cross functional worker. Ability to set and achieve personal performance goals. Provide input to departmental objectives. Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.Develop staff to maximize contributions to the team and the company. Ability to multitask and easily prioritize work. Ability to work independently with little supervision. Proficient in Microsoft Excel, Word and PowerPoint. All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. Role model for company core values of trust, delighting our customers, and Genki. 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 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. 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

Founded in 1898 and headquartered in Chicago, IL, GATX Corporation (NYSE: GATX) is an industry leader with 125+ years of success-success that is powered by our people. At GATX, we hire the best and offer our employees a dynamic, energetic, collaborative environment to enable them to make an impact from day one. Enjoy the perks and benefits of a global company with the close-knit culture and community of a much smaller one. In the same way we strive to empower our customers to propel the world forward, we are dedicated to providing our people with the tools and resources they need to move forward in their careers. In this role, you will lead and direct facility operations at the Hearne Service Center. This position will support the management and execution of the quality program and its components to ensure compliance to regulatory, GATX and customer requirements. This position will also support research and analysis of quality and maintenance related issues and implementation of quality improvements at the facility. Responsibilities Technical Resource Function as a technical resource for GATX personnel throughout the facility Participate on cross-functional teams to evaluate, define, and improve our processes to ensure alignment and achievement of GATX initiatives Apply the GATX Quality program requirements to in-process and/or outbound repairs and support the development of others' quality knowledge Training Perform Quality Training (qualifications, document updates, etc.) Maintain the Quality training database, training records and employee certifications Act as Weld Facilitator for the facility, as needed Gauge Management Manage gauge calibration records Perform calibrations, as needed Provide oversight to ensure calibration requirements are known and adhered to Auditing Serve as liaison for external audits Perform internal audits to confirm compliance with GATX, regulatory and customer requirements Develop reports and supporting details presenting audit results Work with applicable individuals to devise and implement actions to correct deficiencies and follow up on those actions to ensure effectiveness Interaction: The individual in this position will interact with all levels of personnel throughout both the facility and the organization. The primary focus of this position is serving as a technical resource to ensure railcar repairs and all related activities are in compliance with documented repair guidelines prepared by regulatory agencies, railcar engineers and customers. Qualifications Education and/or Experience: High school diploma or equivalent required 3 - 5 years of relevant work experience General Inspector Qualification VT certification or the ability to gain this certification Knowledge and experience in applying structured problem-solving practices (e.g. 5 Whys) Advanced computer skills, including experience or the ability to be proficient with the following systems: MS Office Suite (Word, Excel, and PowerPoint) LCA MMS Shop Portal ECM MIS SEM SharePoint Railinc ETQ Power BI Key Competencies: Strong Core Values (integrity, respect, ownership, teamwork, openness, creativity, positive attitude) Ability to read and interpret technical documents such as QA Documents, IO instructions, FM instructions, work orders, drawings, AAR Field Manual and AAR MSRPs Communication, both verbal and written Other: Must be able to work in extreme temperature environments Must be able to lift up to 50 pounds Must be able to climb ladders and perform work at elevated heights Must be able to walk for extended periods of time Must be able to sit/work in front of a computer for extended periods of time Minimal travel may be required within the US and Canada Posting Duration This posting will remain open until the role is filled. As of the post date, the salary range for this position is: Min USD $78,000.00/Yr. Max USD $86,000.00/Yr. This role may be eligible to participate in the Company's short-term incentive plan, the details of which will be provided to the applicant upon hire. This range is a reasonable estimate and takes into account several factors that are considered in making compensation decisions, including, but not limited to, geographic location, skill set, experience, education, training, internal equity, and other business needs.

The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory. The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to QC Manager, Chemistry Work Location College Station, TX Primary Responsibilities: Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments. Coordinate QC analytical testing for GMP release and stability testing. Ensure QC equipment is maintained in a qualified state. Prepare and execute tech transfer, qualification and validation protocols and reports as needed. Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation. Establish a system for managing test samples, reagents and reference standards. Review and approve data / reports during release & stability testing. Ensures laboratory compliance to established specifications and procedures. Reports excursion/out of specifications results and conducts investigations as needed. Assure the implementation of appropriate and timely corrective actions. Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team. Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support. Interface with current and potential clients as well as interface with investigators during internal and external inspections. Follow all established laboratory, regulatory, safety, and environmental procedures. Identify deviations and report possible preventative and corrective actions. Perform other duties as assigned. Required Skills & Abilities: Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies. Operate as a team leader, coordinate staff scheduling. Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Develop staff to maximize contributions to team and company. Ability to multi-task and prioritize work assignments with little supervision. Excellent attention to detail. Computer proficiency required. Ability to accurately review and complete required documentation. Excellent written and oral communication skills. Excellent organization and analytical skills. Role model for company core values of trust, delighting our customers, and Gemba. 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. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Chemistry or Biochemistry with 3+ years of industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role; OR, Bachelor's degree preferably in Chemistry or Biochemistry with 5+ years industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role. Preferred Qualifications: Analytical laboratory experience in a GLP/GMP regulated environment is preferred. Experience in Trackwise Deviation Management software. Experience in Empower 3 software. 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

Job Description SUMMARY: The QC Manager is responsible for overseeing all aspects of quality assurance and quality control within the fabrication shop. This role ensures that products, processes, and services consistently meet customer, regulatory, and ISO 9001 requirements. The QC Manager will lead inspections, audits, and continuous improvement initiatives to maintain compliance and drive product excellence. RESPONSIBILITIES Develop, implement, and maintain the company's Quality Management System (QMS) in accordance with ISO 9001 standards. Conduct internal audits, manage external audits, and ensure compliance with industry certifications (e.g., ISO, AIS, AWS, customer-specific requirements). Lead root cause analysis and corrective/preventive action (CAPA) programs. Oversee inspection and testing of incoming materials, in-process components, and final products. Verify conformance to blueprints, specifications, weld codes, and project requirements. Ensure calibration and maintenance of measurement tools and testing equipment. Maintain accurate inspection reports, material certifications, weld records, and non- conformance reports. Prepare quality documentation for customer submittals and project closeouts. Track and report on key quality performance metrics (e.g., defect rate, NCRs, rework percentage). Manage and mentor QC inspectors, welding inspectors, and other quality staff. Provide training to shop employees on quality standards, ISO 9001 requirements, and best practices. Foster a culture of quality, accountability, and continuous improvement. Work directly with customers and third-party inspectors during shop inspections and project milestones. Evaluate vendor quality performance and work with supply chain to ensure incoming materials meet standards. Manage subcontractor quality compliance for outsourced processes (e.g., coatings, NDE). QUALIFICATIONS 5+ years of experience in quality management within steel fabrication/ manufacturing. Strong knowledge of ISO 9001 requirements and experience in implementing or maintaining a QMS. Familiarity with welding codes (AWS, ASME) and inspection methods (visual, dimensional, NDE). Strong leadership, communication, and problem-solving skills. Proficient in reading technical drawings, specifications, and standards. Certified Quality Manager or Welding Inspector (CWI) preferred Performance Metrics (KPls) ISO 9001 audit results and compliance status

The Quality Engineer oversees all quality-related activities undertaken to support manufactured products at DTTP, the Products we procure from other sister plants, and the products and accessories we procure from third-party vendors. Responsible for the continuous improvement of the organization's product quality and procedure adherence to ensure quality consistency. Reviews quality standards, tolerances, and engineering changes. Evaluates engineering changes for existing products, outsourced parts, processes and subassemblies, and new products. Analyzes engineering specifications and manufacturing processes for newly introduced products, Develops test plans and quality testing equipment. Monitors periodic warranty reports and drives improvement initiatives. Investigates and analyzes complex quality problems, recommends solutions, and ensures corrections are made. Position Responsibilities may include: Be the advocate for the manufacturing operations and end customers, ensuring all the new products are launched at a better-quality level than the products we currently produce. Through a comprehensive set of established metrics, the Quality Engineer tracks and communicates the current state of product launches and the performance of the products that were launched. Drive a culture of continuous improvement and assuring product quality by virtue of standards adherence. In coordination with others, Tech Services, Quality Control, Reliability, Warranty Analytics, and Supplier Quality, oversee and drive the Corrective and Preventive Actions related to quality issues, directly affecting DTTP operations.  This applies to new products that are manufactured at DTTP and products manufactured at other Daikin sister plants by taking the lead with multidisciplinary teams to drive corresponding efforts to execute corrections to product designs/standards, supplier issues, and even internal manufacturing processes. Communicate internally regarding current quality problems such as 8D's- problem description, status, root cause analysis, and resolution timetable. Create and take the leadership role to complete Development Quality Improvement and Warranty Monitoring reporting activities for all new product launches. Lead and orchestrate all New Product Launch related efforts to minimize the impact on manufacturing operations.  Supervise, train and audit the incoming people and auditors(lab/line) Provide support to production and ensure system adherence Support the implementation of corrective and preventive actions (CPAs). Assist in root cause analysis and problem resolution. Coordinate effectively with the Design, Procurement, Supplier Quality Assurance, and Reliability Departments to ensure that supplier changes and internal changes are fully qualified before implementation.  Ensure thorough validation of design and component changes to avoid any negative impact on metrics. Lead CPAs for products affecting DTTP operations. Conduct intermediate statistical analysis and design of experiments (DOE). Manage moderate-scale projects and lead cross-functional teams. Ensure that the Quality Policy and the Daikin Core Values are: 1) understood at all levels in his/her department, and 2) used as a guide to all decision-making in his/her department.  Ensure smooth operation of the Development Quality Department - Set clear expectations, reasonable work assignments, fair scheduling, equal job opportunity but effective hiring, firm discipline, high-performance team management, transparent budgeting/spending, and environmentally friendly practices.  Perform additional projects/duties to support ongoing business needs. Nature & Scope: Applies advanced knowledge of job area typically obtained through advanced education and work experience. Manages projects and processes while working independently and with limited supervision. Coaches and reviews the work of lower-level professionals. Problems faced are difficult and sometimes complex; takes a new perspective on existing solutions. Knowledge & Skills: Strong interpersonal skills and leadership qualities. Must be able to create a shared vision, a structured plan, and convincing arguments to motivate and lead interdepartmental team members and gain their collaboration in the pursuit of a common goal or project to effectively and timely complete all needed tasks. Solid understanding of HVAC system design and manufacturing processes. Knowledge of field performance and reliability issues specific to HVAC systems or similar industry or products Capable of managing multiple projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Six Sigma and/or Quality Engineering certification will be a plus. Ability to convert data into actionable information and effectively communicate to senior leadership by utilizing statistical methods to characterize and analyze data to find potential solutions to problems and facilitate decision-making. Familiar with data analysis tools, such as Minitab, Excel (pivot tables), Tableau, MAPICS, etc. Proficient use of Advanced tools like Failure Modes and Effects Analysis (FMEA) Intermediate statistical analysis skills, including DOE. Experienced in leading problem-solving skills to identify root causes of quality problems and drive multidisciplinary teams to find and execute solutions by utilizing DMAIC, Design of Experiment Strong problem-solving skills to effectively identify root causes of quality problems and drive multidisciplinary teams to find and execute solutions by utilizing DMAIC, Design of Experiment, 6 sigma methods, FMEA, 8 Disciplines, lean methods, etc. Capable of managing multiple projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Effective communication and presentation skills. Ability to apply good judgment, strong work ethic, and integrity on the job. Develop strategies for effective stakeholder engagement and communication. Solid skills in Engineering standards/drawing interpretation. Strong communication skills, including presentation development, meeting organization/facilitation, clear conveyance & transmission of information through written & verbal form. High level of knowledge in quality management systems with solid technical background (HVAC preference), to drive supplier quality improvements Ability to apply good judgment, strong work ethic, and integrity on the job. Competencies: Experience: 4-6 years of experience in Quality Engineering. Education/Certification: Bachelor's degree in Engineering (Mechanical, Industrial, or related field). Master degree is a plus Six Sigma Green Belt or Black Belt equivalent preferred. People Management: No Physical Requirements / Work Environment: Must be able to perform essential responsibilities with or without reasonable accommodations Reports To: Quality Manager, Quality Director Qualified Applicants must be legally authorized for employment in the United States. Qualified applicants will not require employer-sponsored work authorization now or in the future for employment in the United States. The Company provides equal employment opportunity to all employees and applicants regardless of a person's race, color, religion (including religious dress or grooming practices), creed, national origin (including language use restrictions), citizenship, uniform service member or veteran status, ancestry, disability, physical or mental disability (including HIV/AIDS), medical condition (including cancer and genetic characteristics), genetic information, request for protected leave, marital status, sex, pregnancy, age (over 40), sexual orientation, gender, gender identity or expression, political affiliation, or any other characteristic protected by law. The Company will comply with all federal and state regulations and statutes pertaining to individuals with disabilities.

Job Description The Quality Engineer oversees all quality-related activities undertaken to support manufactured products at DTTP, the Products we procure from other sister plants, and the products and accessories we procure from third-party vendors. Responsible for the continuous improvement of the organization's product quality and procedure adherence to ensure quality consistency. Reviews quality standards, tolerances, and engineering changes. Evaluates engineering changes for existing products, outsourced parts, processes and subassemblies, and new products. Analyzes engineering specifications and manufacturing processes for newly introduced products, Develops test plans and quality testing equipment. Monitors periodic warranty reports and drives improvement initiatives. Investigates and analyzes complex quality problems, recommends solutions, and ensures corrections are made. Position Responsibilities may include: Be the advocate for the manufacturing operations and end customers, ensuring all the new products are launched at a better-quality level than the products we currently produce. Through a comprehensive set of established metrics, the Quality Engineer tracks and communicates the current state of product launches and the performance of the products that were launched. Drive a culture of continuous improvement and assuring product quality by virtue of standards adherence. In coordination with others, Tech Services, Quality Control, Reliability, Warranty Analytics, and Supplier Quality, oversee and drive the Corrective and Preventive Actions related to quality issues, directly affecting DTTP operations. This applies to new products that are manufactured at DTTP and products manufactured at other Daikin sister plants by taking the lead with multidisciplinary teams to drive corresponding efforts to execute corrections to product designs/standards, supplier issues, and even internal manufacturing processes. Communicate internally regarding current quality problems such as 8D's- problem description, status, root cause analysis, and resolution timetable. Create and take the leadership role to complete Development Quality Improvement and Warranty Monitoring reporting activities for all new product launches. Lead and orchestrate all New Product Launch related efforts to minimize the impact on manufacturing operations. Supervise, train and audit the incoming people and auditors(lab/line) Provide support to production and ensure system adherence Support the implementation of corrective and preventive actions (CPAs). Assist in root cause analysis and problem resolution. Coordinate effectively with the Design, Procurement, Supplier Quality Assurance, and Reliability Departments to ensure that supplier changes and internal changes are fully qualified after implementation. Ensure thorough validation of design and component changes to avoid any negative impact on metrics. Lead CPAs for products affecting DTTP operations. Conduct intermediate statistical analysis and design of experiments (DOE). Manage moderate-scale projects and lead cross-functional teams. Ensure that the Quality Policy and the Daikin Core Values are: 1) understood at all levels in his/her department, and 2) used as a guide to all decision-making in his/her department. Ensure smooth operation of the Development Quality Department - Set clear expectations, reasonable work assignments, fair scheduling, equal job opportunity but effective hiring, firm discipline, high-performance team management, transparent budgeting/spending, and environmentally friendly practices. Perform additional projects/duties to support ongoing business needs. Nature & Scope: Applies advanced knowledge of job area typically obtained through advanced education and work experience. Manages projects and processes while working independently and with limited supervision. Coaches and reviews the work of lower-level professionals. Problems faced are difficult and sometimes complex; takes a new perspective on existing solutions. Knowledge & Skills: Strong interpersonal skills and leadership qualities. Must be able to create a shared vision, a structured plan, and convincing arguments to motivate and lead interdepartmental team members and gain their collaboration in the pursuit of a common goal or project to effectively and timely complete all needed tasks. Solid understanding of HVAC system design and manufacturing processes. Knowledge of field performance and reliability issues specific to HVAC systems or similar industry or products Capable of managing multiple projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Six Sigma and/or Quality Engineering certification will be a plus. Ability to convert data into actionable information and effectively communicate to senior leadership by utilizing statistical methods to characterize and analyze data to find potential solutions to problems and facilitate decision-making. Familiar with data analysis tools, such as Minitab, Excel (pivot tables), Tableau, MAPICS, etc. Proficient use of Advanced tools like Failure Modes and Effects Analysis (FMEA) Intermediate statistical analysis skills, including DOE. Experienced in leading problem-solving skills to identify root causes of quality problems and drive multidisciplinary teams to find and execute solutions by utilizing DMAIC, Design of Experiment Strong problem-solving skills to effectively identify root causes of quality problems and drive multidisciplinary teams to find and execute solutions by utilizing DMAIC, Design of Experiment, 6 sigma methods, FMEA, 8 Disciplines, lean methods, etc. Capable of managing multiple projects and activities with a high level of urgency by using the PDCA approach to deliver quick but effective results. Effective communication and presentation skills. Ability to apply good judgment, strong work ethic, and integrity on the job. Develop strategies for effective stakeholder engagement and communication. Solid skills in Engineering standards/drawing interpretation. Strong communication skills, including presentation development, meeting organization/facilitation, clear conveyance & transmission of information through written & verbal form. High level of knowledge in quality management systems with solid technical background (HVAC preference), to drive supplier quality improvements Ability to apply good judgment, strong work ethic, and integrity on the job. Competencies: Experience: 4-6 years of experience in Quality Engineering. Education/Certification: Bachelor's degree in Engineering (Mechanical, Industrial, or related field). Master degree is a plus Six Sigma Green Belt or Black Belt equivalent preferred. People Management: No Physical Requirements / Work Environment: Must be able to perform essential responsibilities with or without reasonable accommodations Reports To: Quality Manager, Quality Director Qualified Applicants must be legally authorized for employment in the United States. Qualified applicants will not require employer-sponsored work authorization now or in the future for employment in the United States. The Company provides equal employment opportunity to all employees and applicants regardless of a person's race, color, religion (including religious dress or grooming practices), creed, national origin (including language use restrictions), citizenship, uniform service member or veteran status, ancestry, disability, physical or mental disability (including HIV/AIDS), medical condition (including cancer and genetic characteristics), genetic information, request for protected leave, marital status, sex, pregnancy, age (over 40), sexual orientation, gender, gender identity or expression, political affiliation, or any other characteristic protected by law. The Company will comply with all federal and state regulations and statutes pertaining to individuals with disabilities.

A proactive and driven team player is required to passionately support delivery and embedding of the Data Integrity projects at FUJIFILM Biotechnologies, Texas. The Quality Assurance (QA) Specialist II for Data Integrity will be responsible for the day to day running of the FUJIFILM Biotechnologies, Texas Data Integrity Program, performing data integrity assessments, gap confirmation and risk assessments, generate remediation plans and categorize gaps based on business priority and risks. **Reports to** Senior Director, QA Compliance **Work Location** College Station, TX **Company Overview** The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** **Job Description** **Primary Responsibilities:** + Work collaboratively with all levels of the FUJIFILM Biotechnologies, Texas site to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. + Act as an ambassador for FUJIFILM Biotechnologies, Texas Quality Culture. + Deputize fronting Data Integrity in customer and regulatory audits (as required). + Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products. + Work as a change agent to compliantly improve existing or introduce new ways of working. + Strong experience with GMP, manufacturing processes, quality and regulatory requirements. + Ensure smooth operation of the FUJIFILM Biotechnoloigies, Texas Data Integrity program highlighting any issues in a timely manner. + Provide guidance and advice to ensure Data Integrity remediation actions are successfully completed. + Provide coaching and training for staff in Data Integrity Principles. + Engage in global FUJIFILM Biotechnologies projects and meetings to include being an active participant in work groups, and assessment of existing and new global systems. + Schedule and perform assessments, gap confirmation and schedule stakeholder follow-up. + Review pre-purchase of systems and analyze to ensure Data Integrity Compliance. + Draft FMEAs and lead stakeholder meetings. + Raise and manage change controls and CAPAs, and drive mitigation and remediation. + All other duties as assigned. **Qualifications:** + Bachelor's degree in a related science concentration with 2+ years of experience of cGMP supporting pharmaceutical or biotechnology products or 1 year experience with FUJIFILM Biotechnologies with a related role; OR, + Associate's 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; + High School or equivalent and 6+ years of experience of cGMP supporting pharmaceutical or biotechnology products. + Involvement in Data Integrity projects during previous roles preferred. + Ability to collaborate effectively with stakeholders from across the business, at all levels. + Excellent written and oral communication skills. + Excellent organizational, analytical, data review and report writing skills. + Motivated cross functional worker. + Ability to set and achieve personal performance goals. + Provide input to departmental objectives. + Strong understanding of 21 CFR Part 11 and Annex 11 regulations, FDA, GMP, GAMP and ISPE.Develop staff to maximize contributions to the team and the company. + Ability to multitask and easily prioritize work. + Ability to work independently with little supervision. + Proficient in Microsoft Excel, Word and PowerPoint. + All candidates must have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products. + Role model for company core values of trust, delighting our customers, and Genki. **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 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. _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._ **EEO Information** Fujifilm is committed to 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. **ADA Information** If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************. **Job Locations** _US-TX-College Station_ **Posted Date** _4 months ago_ _(8/15/2025 11:43 AM)_ **_Requisition ID_** _2025-35370_ **_Category_** _Quality Assurance_ **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_

The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory. The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description Reports to QC Manager, Chemistry Work Location College Station, TX Primary Responsibilities: Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments. Coordinate QC analytical testing for GMP release and stability testing. Ensure QC equipment is maintained in a qualified state. Prepare and execute tech transfer, qualification and validation protocols and reports as needed. Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation. Establish a system for managing test samples, reagents and reference standards. Review and approve data / reports during release & stability testing. Ensures laboratory compliance to established specifications and procedures. Reports excursion/out of specifications results and conducts investigations as needed. Assure the implementation of appropriate and timely corrective actions. Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team. Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support. Interface with current and potential clients as well as interface with investigators during internal and external inspections. Follow all established laboratory, regulatory, safety, and environmental procedures. Identify deviations and report possible preventative and corrective actions. Perform other duties as assigned. Required Skills & Abilities: Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies. Operate as a team leader, coordinate staff scheduling. Ability to follow safety procedures outlined in the Chemical Hygiene Plan. Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. Develop staff to maximize contributions to team and company. Ability to multi-task and prioritize work assignments with little supervision. Excellent attention to detail. Computer proficiency required. Ability to accurately review and complete required documentation. Excellent written and oral communication skills. Excellent organization and analytical skills. Role model for company core values of trust, delighting our customers, and Gemba. 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. Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. Ability to sit for long periods to work on a computer. Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. Attendance is mandatory. Minimum Qualifications: Master's degree preferably in Chemistry or Biochemistry with 3+ years of industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role; OR, Bachelor's degree preferably in Chemistry or Biochemistry with 5+ years industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role. Preferred Qualifications: Analytical laboratory experience in a GLP/GMP regulated environment is preferred. Experience in Trackwise Deviation Management software. Experience in Empower 3 software. 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.

The Quality Control Chemistry Supervisor, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC Chemistry staff as well as coordinating the installation and qualification of new analytical equipment in support of GMP release and stability testing. The Chemistry Supervisor will lead tech transfer activities of qualified analytical methods from a designated donor laboratory. The Chemistry Supervisor will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory. Company Overview The work we do at FUJIFILM Biotechnologies Texas has never been more important-and we are looking for passionate, mission-driven people like you who want to make a real difference in people's lives. From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions. If you're ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drive-what we call Genki. Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description Reports to QC Manager, Chemistry Work Location College Station, TX Primary Responsibilities: * Supervise and lead the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments. * Coordinate QC analytical testing for GMP release and stability testing. * Ensure QC equipment is maintained in a qualified state. * Prepare and execute tech transfer, qualification and validation protocols and reports as needed. * Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation. * Establish a system for managing test samples, reagents and reference standards. * Review and approve data / reports during release & stability testing. * Ensures laboratory compliance to established specifications and procedures. * Reports excursion/out of specifications results and conducts investigations as needed. * Assure the implementation of appropriate and timely corrective actions. * Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management team. * Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support. * Interface with current and potential clients as well as interface with investigators during internal and external inspections. * Follow all established laboratory, regulatory, safety, and environmental procedures. * Identify deviations and report possible preventative and corrective actions. * Perform other duties as assigned. Required Skills & Abilities: * Sound understanding and knowledge of SEC, UPLC, and Capillary Electrophoresis instrumentation and methodologies. * Operate as a team leader, coordinate staff scheduling. * Ability to follow safety procedures outlined in the Chemical Hygiene Plan. * Utilize MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated. * Develop staff to maximize contributions to team and company. * Ability to multi-task and prioritize work assignments with little supervision. * Excellent attention to detail. * Computer proficiency required. * Ability to accurately review and complete required documentation. * Excellent written and oral communication skills. * Excellent organization and analytical skills. * Role model for company core values of trust, delighting our customers, and Gemba. 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. * Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. * Ability to sit for long periods to work on a computer. * Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials. * Ability to wear personal protective equipment including safety glasses, lab coat, and gloves. * Attendance is mandatory. Minimum Qualifications: * Master's degree preferably in Chemistry or Biochemistry with 3+ years of industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role; OR, * Bachelor's degree preferably in Chemistry or Biochemistry with 5+ years industry experience in a GMP / GxP or a comparable federally regulated environment of which 2+ years are in a lead or supervisory role. Preferred Qualifications: * Analytical laboratory experience in a GLP/GMP regulated environment is preferred. * Experience in Trackwise Deviation Management software. * Experience in Empower 3 software. 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. EEO Information Fujifilm is committed to 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. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (******************* or ***************.