Director, QA Compliance - Audits & Inspections
Quality assurance specialist job in College Station, TX
The Director Quality Systems is responsible for developing, implementing, and maintaining individual sub-systems of the Pharmaceutical Quality Systems (PQS) for FUJIFILM Biotechnologies in TX. Responsibilities will include one or more PQS sub-system: Internal Audit, External (Customer) Audit, Health Authority Inspection, and Remediation. Lead the assigned team to create a strong quality culture of engaged and motivated staff maintaining strong working relationships with internal and external stakeholders. Ensure the site PQS sub-system is aligned with the harmonized global FUJIFILM Biotechnologies PQS, organizational goals and objectives, and areas of continuous improvement.
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:
Develop, implement, and maintain the risk-based PQS sub-systems to meet all CGMP regulatory requirements for phase-appropriate clinical and commercial bulk drug substance and drug product manufacture.
Establish governance and oversight processes to ensure the organization is continuously complying with site and global quality standards, regulatory requirements, and partner commitments.
Lead the Quality Compliance team to deliver exceptional performance of each assigned sub-system.
Internal Audit.
External (Customer) Audit.
Health Auditory Inspection & Remediation.
Liaise with internal and external stakeholders to achieve expected business outcomes.
Partner with Quality Compliance to ensure the site is inspection ready at all times.
Implement audit/inspection learnings within the site QMS; share learnings between FDB sites.
Identify areas of risk and/or continuous improvement; escalate/communicate as appropriate.
Provide expert guidance and interpretation on regulatory requirements.
Recruit, hire, and manage the team in line with FDBT policies and practices.
Ability to serve as deputy for Senior Director Quality Systems.
Any other duties as assigned.
Qualifications:
Bachelor's degree with 10+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment; OR,
Associate's degree with 12+ years of relevant experience in a regulated pharmaceutical, biotechnology, or supporting a CDMO environment.
6+ years of experience in a supervisory or managerial role.
5+ years of experience working with biologics (vaccines, gene therapy, mAb, etc.) in a QA or QC role.
Experience with biologics - vaccines, gene therapy, mAb, etc., preferred.
Experience within CDMO preferred.
Advanced Degree preferred.
ASQ Certification preferred.
Expert understanding of Pharmaceutical Quality Systems.
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 substance, drug product, biologics, vaccine, and/or advanced therapy 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.
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 ***************.
Auto-ApplyQA Specialist II, Data Integrity
Quality assurance specialist job in College Station, TX
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 ***************.
Auto-ApplyQA Specialist III, Data Integrity
Quality assurance specialist job in College Station, TX
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 ***************.
Auto-ApplyPart-Time Support Documentation Specialist
Quality assurance specialist job in College Station, TX
":"As a Part-time Key Product Research and Development specialist, you will assist our KEY control product specialists with research and development through testing and evaluating products. Some of your duties could involve resolving issues with PC systems, proprietary software, peripheral hardware, operating systems, networks and GPS technologies in a challenging but rewarding environment.
Associates in this position develop hardware testing and production processes while assisting Key Product teams support a diverse customer base ranging from automotive dealers to government entities.
","job_category":"Administrative and Clerical","job_state":"TX","job_title":"Part-Time Support Documentation Specialist","date":"2025-11-20","zip":"77840","position_type":"Part-Time","salary_max":"0","salary_min":"0","requirements":"High school diploma or GED~^~PC skills~^~Troubleshooting skills~^~Professional verbal communication skills~^~Technical documentation skills, a plus","training":"On-the-job paid training that appeals to various learning styles is provided and includes: instructor-led courses, reference documentation, hands-on training with labs, and shadowing current support representatives.
Training lasts approximately 6 weeks.
","benefits":"","
Supv Quality Assurance
Quality assurance specialist job in Hearne, TX
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.
Auto-ApplyPT Quality Assurance Associate
Quality assurance specialist job in College Station, TX
Primary Purpose:
Provide our customers with a clean, safe, inviting place to shop by maintaining standards in accordance with the standard practice manual. Minimize shrink through proper utilization of standard practice.
Duties and Responsibilities:
· Maintain an atmosphere of enthusiastic customer awareness with primary emphasis on fast, friendly, and accurate customer service to create a positive shopping experience
· Courteous and helpful to other associates
· Sweep and clean floors on nights with no scheduled vendor services
· Weekly cleaning of Produce, Market and Deli Departments
· Clean and organize the store mop room
· Find more efficient ways to do the job and seek to reduce costs and improve labor productivity
· Follow QA daily check list and sanitation standards set by Food Lion
· Follow current Standard Practices regarding cleanup of Hazardous Waste product
· Maintain a complete understanding of and adherence to company guidelines, policies and standard practice
· Understand and follow Food Safety and Workplace Safety guidelines and procedures
· Observe and correct all unsafe conditions that could cause associate or customer accidents
· Report all associate and customer accidents in accordance with established Food Lion procedures to the Manager on Duty
· Ensure compliance with local, state and federal regulations
· Wear the Food Lion uniform complete with name badge, when on duty, has a neat and clean appearance while adhering to the Food Lion dress code
· Successfully complete Computer Based Training (CBT), Training Packet and Training Aid courses
· Perform all other duties as assigned
Qualifications:
· High school graduate or equivalent preferred
· Excellent interpersonal, organizational, communication and customer service skills
· Ability and willingness to learn multiple tasks and technical requirements of the job
· Ability to use technical information to solve problems
· Must meet minimum age requirements to perform specific job functions
· Must be able to meet the physical requirements of the position, with or without reasonable accommodations
Physical Requirements:
· Ability to use computers and other communication systems required to perform job functions
· Perform repetitive hand and arm motions
· Bend and lift products weighing up to 15 lbs. continuously, 25 lbs. frequently, and 50 lbs. on occasion
· Pull or push up to 75 lbs. on occasion
· Stand 100% of the time, frequently walking short distances
· Be able to handle a variety of substances associated with cleaning and packaging materials, fresh fruits, vegetables, house plants/flowers and household cleaners
· Use hands to frequently/continuously handle currency (paper and coin) as well as operate a variety of equipment such as cash register, lottery machine (where applicable), scanner, computer, and calculator
· Frequent reaching and grasping at waist level: occasionally above shoulder or below waist level
· Meet established volume activity standards for the position
· Tolerate working in extreme hot/cold temperatures for up to 20 minutes at a time
· Have sufficient visual ability to check ID cards, checks, invoices and other written documents
QA Supervisor, Operations
Quality assurance specialist job 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 ***************.
Auto-ApplyQuality Associate
Quality assurance specialist job in Magnolia, TX
Quality Assoicate
Open until filled. Magnolia, Texas.
Essentials Duties and Responsibilities
· Maintain the Quality Management System (QMS)
· Maintain Quality Records and Logs
· Management of quarantine material
· Investigates customer returns
· Reviewing of all documentation and product for product quality, completeness, correctness as well as adherence to any special customer requirements
· Authorization to Ship requests
· Corrective Actions
· Physical and documentation inspections
· ISO9001, AS9100D and Safety required training
· Coordinate machine maintenance with the warehouse
· Coordinate facility inspections
· Maintain calibration records
· All other duties as assigned
Requirements
Qualifications, Knowledge, & Skills:
· High School Diploma or equivalent, college degree preferred
· 3 to 5 years of experience in related field preferred (academically or professionally)
· Ability to read specifications, measure product, review product, labeling, packaging, certifications, and sign off on end item acceptance, and inspect incoming product and paperwork from vendors
· Computer skills required for maintenance of records and logs, and basic analysis of data (e.g., Excel spreadsheet).
· Good problem-solving skills and high level of attention to detail.
· Good interpersonal, oral and written communication skills
Physical Requirements:
Must be able to work in an office setting and warehouse setting (desk work and physical work)
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift up to 60 pounds at times.
Benefits:
Bron Tapes offers a full benefits package after 60 days of employment.
401k with match (after 60 says of employment)
Medical - United Healthcare
Dental - United Healthcare
Vision - United Healthcare
Flexible Spending Accounts
Short- and Long-Term Disability Insurance
Life Insurance
Employee Assistance Program (EAP)
MetLifePlans (Accident, Legal, Critical Illness & Hospital Indemnity)
ID Theft Protection
Paid Vacation and Sick Time
Job description statements are intended to describe the general nature and level of work being performed by employees assigned to this job title. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skilled required.
Bron Tapes, Inc (including all subsidiaries: NSL Aerospace, Bron Converting, Inc., Bron Aerotech, Inc., and Bron Holding, Inc.) is an equal opportunity employer. All employment is decided on the basis of qualifications, merit, and business need, qualitied persons will not be denied employment opportunity based on race, color, national origin, religion, sex, sexual orientation, gender identity, age, disability, genetic information
, marital status,
veteran status or any other basis covered by appropriate law. Any questions about our EEO policy should be directed to Human Resources.
Bron Tapes, Inc (including all subsidiaries: NSL Aerospace, Bron Converting, Inc., Bron Aerotech, Inc., and Bron Holding, Inc.) is an E-Verify employer.
Salary Description $15.00-$25.00/hr DOE
Center Quality Assurance Supervisor
Quality assurance specialist job in Huntsville, TX
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
AUDITOR QUALITY 2
Quality assurance specialist job in Waller, TX
Job Description
The Quality Auditor is responsible for all aspects of the internal quality systems audit program, including, but not limited to: audit planning, execution, follow-up and re-audit, if necessary. Maintaining audit systems and information management. QA auditor reviews protocols, qualification, and validation procedures documented by the organization. The QA Auditor is expected to follow the procedures and drive consistency of criterion and auditing best practices across the organization. If a manufactured product does not meet quality specifications, the QA Auditor investigates and reports the findings. The Quality Auditor is results and compliant orientated, has a dedication to excellence and sense of urgency to achieve business objectives.
Position Responsibilities may include:
• Audit the Fabrication and Assembly areas for ISO compliance by conducting Process and Product Audits
• Document Non-Conformances
• Collaborate with the production departments to identify root causes and implement corrective actions
• Review engineering BOM and drawings and provide feedback
• Assist Quality leadership in continuous improvement projects as assigned
• Document and maintain technical reports and complete all required documentation timely and accurately
• Bring to the Managers attention, any ideas or opportunities for CIP or QIP
• Follow all safety procedures including wearing appropriate PPE when required
• 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:
• Working knowledge of MS Office - Outlook, Excel, and Word (Proficiency with MS Excel is preferred)
• Effective verbal and written communication skills
• Moderate Knowledge on reading and following Bill of Material
• Moderate knowledge on engineering drawing
• Moderate knowledge on using handheld measuring tools
• Ability to understand mechanical and electrical test equipment
• Prepare statistical information is strongly preferred
• Ability to work with MAPICS/AS400 and PowerLink
• understanding of the ISO 9001/14001 requirements
• Basic Knowledge on Area-base inspection process
• Ability to apply good judgment, strong work ethic, and integrity on the job.
Experience:
• 3 year of quality experience
Education/Certification:
• High School diploma or GED
People Management: No
Physical Requirements / Work Environment:
• Must be able to perform essential responsibilities with or without reasonable accommodations
Reports To: Supervisor, Quality
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.
Specialist I - Testing Specialist I (part-time, hourly) - 2 positions to be filled
Quality assurance specialist job in Huntsville, TX
Come and join the Bearkat community! Named after Texas' legendary hero, General Sam Houston, the university boasts a rich historical legacy that resonates with the spirit of Texas, which provides a balance between a peaceful, natural setting and proximity to urban amenities. With a student population of over 21,000, SHSU offers a vibrant and dynamic community. SHSU has a small town feel with large scale opportunities. Located in the Piney Woods region of East Texas and just an hour drive north of Houston, Huntsville provides area residents with a sense of community and belonging.
SHSU offers compelling options for individuals seeking a fulfilling and impactful career including a superior benefit package, competitive salaries and a flexible work environment fostering work/life balance. SHSU offers programs that support a healthy work-life balance, contributing to employee well-being and job satisfaction, as well as, professional development opportunities with our educational assistance and dependent assistance programs.
Posting Information
This position is security-sensitive and thereby subject to the provisions of the Texas Education Code §51.215, which authorizes the employer to obtain criminal history record information.
Requisition 202500354S Title Specialist I - Testing Specialist I (part-time, hourly) - 2 positions to be filled FLSA status Non-Exempt Hiring Salary
$15.00 per hour: This position is a pay grade 2. Please see Pay Grade Table at: ******************************************************************
This is a part-time, hourly, non-benefits eligible position working 19 hours or less per week.
Occupational Category Technical/Para-Professional Department Testing Center Division Division of Enrollment Open Date 11/06/2025 Open Until Filled Yes Educational and Experience Requirement
High School graduate or G.E.D. equivalent. Associate degree desirable. Higher-education experience in standardized and academic testing preferred.
Nature & Purpose of Position
Provides essential front-line support to the Testing Center, assisting in both proctoring exams and front-desk operations. Working closely with the Coordinator II, this role ensures a welcoming, efficient environment for students, faculty, and community members.
Primary Responsibilities
Supports the Testing Center's mission by proctoring exams in accordance with established policies, ensuring test security, and assisting candidates through the check-in and test-taking process. Monitors test sessions vigilantly to maintain exam integrity, addresses any disruptions professionally, and promptly reports issues to the Coordinator II or Director. Assists with front-desk responsibilities, welcoming candidates, answering phones, and providing information on Testing Center policies and procedures. Responds to basic inquiries, phone and email, in a friendly, helpful manner and refers more complex questions or issues to the Coordinator II or Director. Maintains a positive, customer-focused demeanor to ensure a supportive environment for all who interact with the Testing Center. Aids in coordinating candidate check-ins, appointment scheduling, and daily activity flow within the Center to ensure smooth operations. Assists with daily Center preparations and confirming appointments, providing flexibility and support during peak testing times. Assists in the consistent communication of Testing Center policies and procedures to candidates, faculty, and staff. Follows established guidelines for exam administration and Center operations, ensuring compliance with testing standards. Maintains awareness of any procedural updates and participates in required training to stay informed on Testing Center policies. Assists in maintaining accurate records and contributes to reporting processes as directed by the Coordinator II or Director to support data-driven decision-making. Demonstrates a friendly, professional attitude in all interactions, focused on delivering a positive experience to students, faculty, and community members. Ensures each candidate feels supported and informed, aligning with the Testing Center's customer-first approach. Performs other related duties as assigned.
Other Specifications
Comfortable using standard office software and testing platforms, with the ability to quickly adapt to specific Testing Center systems. Capable of basic troubleshooting of testing equipment under supervision, reporting technical issues promptly to the Coordinator II. Maintains composure and efficiency in a fast-paced environment, managing multiple tasks and changing priorities smoothly. Participates in ongoing training and maintains required certifications for Testing Center operations. Occasional participation in weekend shifts and evenings required, with occasional travel to The Woodlands Center location for university events. This position requires flexibility, attention to detail, and a commitment to customer service to enhance the Center's overall effectiveness.
The Part-Time Specialist will work on a rotational schedule up to 19 hours per week, as needed, based on Center demand and needs.
Full Time Part Time Part Time Position Number Quicklink *******************************************
AUDITOR QUALITY 2
Quality assurance specialist job in Waller, TX
The Quality Auditor is responsible for all aspects of the internal quality systems audit program, including, but not limited to: audit planning, execution, follow-up and re-audit, if necessary. Maintaining audit systems and information management. QA auditor reviews protocols, qualification, and validation procedures documented by the organization. The QA Auditor is expected to follow the procedures and drive consistency of criterion and auditing best practices across the organization. If a manufactured product does not meet quality specifications, the QA Auditor investigates and reports the findings. The Quality Auditor is results and compliant orientated, has a dedication to excellence and sense of urgency to achieve business objectives.
Position Responsibilities may include:
* Audit the Fabrication and Assembly areas for ISO compliance by conducting Process and Product Audits
* Document Non-Conformances
* Collaborate with the production departments to identify root causes and implement corrective actions
* Review engineering BOM and drawings and provide feedback
* Assist Quality leadership in continuous improvement projects as assigned
* Document and maintain technical reports and complete all required documentation timely and accurately
* Bring to the Managers attention, any ideas or opportunities for CIP or QIP
* Follow all safety procedures including wearing appropriate PPE when required
* 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:
* Working knowledge of MS Office - Outlook, Excel, and Word (Proficiency with MS Excel is preferred)
* Effective verbal and written communication skills
* Moderate Knowledge on reading and following Bill of Material
* Moderate knowledge on engineering drawing
* Moderate knowledge on using handheld measuring tools
* Ability to understand mechanical and electrical test equipment
* Prepare statistical information is strongly preferred
* Ability to work with MAPICS/AS400 and PowerLink
* understanding of the ISO 9001/14001 requirements
* Basic Knowledge on Area-base inspection process
* Ability to apply good judgment, strong work ethic, and integrity on the job.
Experience:
* 3 year of quality experience
Education/Certification:
* High School diploma or GED
People Management: No
Physical Requirements / Work Environment:
* Must be able to perform essential responsibilities with or without reasonable accommodations
Reports To: Supervisor, Quality
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.
Testing Specialist
Quality assurance specialist job in Navasota, TX
Job Title: Testing Specialist Retirees of the Texas Teachers Retirement System (TRS) may apply. Consistent with district policy SD-7.17 "Employment of Retirees," selected applicants are responsible for reimbursing the district, through payroll deduction, for the current rate of all TRS pension or TRS Care surcharges. As of September 1, 2025, the TRS pension surcharge rate is 16.5% and the TRS Care surcharge is $535/month.
Wage/Hour Status: Nonexempt
Pay Group: S25 Salary Plan
Primary Purpose: Administer and/or assist in testing programs throughout the district.
Qualifications:
Education/Certification/Experience:
Bachelor's degree from an accredited four-year college/university accredited by an organization recognized by the Council for Higher Education Accreditation (CHEA) or by the United States Department of Education (USDE).
OR
High school diploma from an accredited high school, high school equivalency certificate (GED, HiSET, or TASC) and two years full-time, wage-earning experience administering occupational aptitude or educational tests.
This position requires personal technology that will enable the completion of job duties and responsibilities when working remotely.
Special Knowledge/Skills:
Knowledge of testing and test security procedures preferred.
Ability to communicate ideas and instructions clearly and concisely.
Ability to proofread with accuracy preferred.
Skill in organizing and maintaining accurate records.
Skill to interpret and apply rules, regulations, policies and procedures.
Major Responsibilities and Duties:
1. Administers and/or assists in the administration of high school equivalency exams.
2. Administer and/or assist in the administration of educational achievement tests.
3. Administer and/or assist in the administration of vocational and language assessments.
4. Establish and maintain security of all test materials and test booklets.
5. Organize and plan test sessions.
6. Examine all test documentation for accuracy and correctness.
7. Arrange for the timely delivery of test materials to the assigned campuses.
8. Assist in compiling statistical test information and reports.
9. Assist in the dissemination of diagnostic data.
10. Maintain test records.
11. Develop procedures for the efficient and accurate flow of information, reports, and test data for the units in the region and central administration offices.
12. Perform other duties as assigned.
Policy, Reports, and Law:
13. Maintain confidentiality in handling sensitive information received in the performance of the job duties.
14. Perform duties in a professional manner through daily, punctual attendance at location of work assignment.
15. Follow Windham School District policies and procedures in completing assigned job duties.
16. Execute duties in a professional, ethical, and responsible manner as defined in 19 TAC Chapter 247, Code of Ethics and Standard Practices for Texas Educators.
Supervisory Responsibilities: None.
Working Conditions
Additional Requirements With or Without Reasonable Accommodation
Mental Demands:
Ability to communicate (verbal and written), ability to instruct, ability to speak, ability to reason, ability to compile data, ability to interpret policy, ability to interpret procedures and data, ability to concentrate, ability to memorize, ability to alphabetize, ability to understand verbal and written instructions, ability to organize, ability to analyze, ability to maintain emotional control, ability to maintain confidentiality, ability to work with frequent interruptions.
Physical Demands:
Ability to perform full duties of position, lift and carry less than 31 pounds, walking, sitting, standing, climbing stairs and ramps, kneeling, stooping, reaching, hearing (with aid), visual acuity, speaking, travel by car, van, or airplane, driving of car/van, distinguishing colors, occasional prolonged and irregular work hours.
Environmental Demands:
Work inside and outside, noise, radiant/electrical energy, work alone, work with others, around machines with moving parts and objects, possible exposure to microwaves in use, exposure to hot and cold temperatures, exposure to dust and cleaning chemicals.
The foregoing statements describe the general purpose and responsibilities assigned to this job and are not an exhaustive list of all responsibilities and duties that may be assigned or skills that may be required.
QA Specialist II, Data Integrity
Quality assurance specialist job in College Station, TX
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_
Supv Quality Assurance
Quality assurance specialist job in Hearne, TX
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.
Auto-ApplyQA Analyst III
Quality assurance specialist job in College Station, TX
The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.
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 Director, Quality Assurance/Senior Manager, Quality Assurance
Work Location College Station, TX (On-site at NCTM building)
Primary Responsibilities:
* Review and/or approve basic and technical documentation with minimal supervisory oversight 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
* Trending QA data
* Draft and review internal Quality policies, procedures, and reports.
* Perform inspection of final product containers and review and/or approval of executed process records and data.
* Perform 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 and client audits
* Identify process and Quality System improvement opportunities.
* Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
* Support Regulatory, client, and internal audits.
* Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
* Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
* Assist with technical oversight/training for the QA team.
* Assist with compliance related functions.
* All other duties as assigned.
Qualifications:
* Master's Degree and 1+ years' experience in Pharmaceutical or other regulated industry.
* Bachelor's degree and 3+ years' experience in Pharmaceutical or other regulated industry.
* Associates Degree and 5+ years' experience in Pharmaceutical or other regulated industry.
* High school or equivalent and 8+ years' experience in Pharmaceutical or other regulated industry.
* Certified Quality Auditor preferred.
* Degree in Biology or Chemistry 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.
* Ability to multitask and easily prioritize your 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.
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.
* 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.
* 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 ***************.
Auto-ApplyQA Analyst III
Quality assurance specialist job in College Station, TX
The Quality Assurance (QA) Analyst III, under minimal direction, will be responsible for review and/or approval of basic and technical documentation, drafting and reviewing of internal Quality policies and procedures, performing product related activities, performing Quality audit functions, performing product release activities, identifying process and Quality System improvements, and acting as a QA liaison internally and externally.
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 Director, Quality Assurance/Senior Manager, Quality Assurance
Work Location College Station, TX (On-site at NCTM building)
Primary Responsibilities:
Review and/or approve basic and technical documentation with minimal supervisory oversight 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
Trending QA data
Draft and review internal Quality policies, procedures, and reports.
Perform inspection of final product containers and review and/or approval of executed process records and data.
Perform 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 and client audits
Identify process and Quality System improvement opportunities.
Provide daily guidance for the compliance of the QA department to national and international standards and regulations.
Support Regulatory, client, and internal audits.
Act as QA liaison to internal Departments and external Client Quality Groups and Vendor/Contract Laboratory Quality Groups.
Promptly notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Assist with technical oversight/training for the QA team.
Assist with compliance related functions.
All other duties as assigned.
Qualifications:
Master's Degree and 1+ years' experience in Pharmaceutical or other regulated industry.
Bachelor's degree and 3+ years' experience in Pharmaceutical or other regulated industry.
Associates Degree and 5+ years' experience in Pharmaceutical or other regulated industry.
High school or equivalent and 8+ years' experience in Pharmaceutical or other regulated industry.
Certified Quality Auditor preferred.
Degree in Biology or Chemistry 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.
Ability to multitask and easily prioritize your 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.
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.
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.
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 ***************.
Auto-ApplyQC Supervisor, Chemistry
Quality assurance specialist job in College Station, TX
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 ***************.
Auto-ApplyAUDITOR QUALITY 1
Quality assurance specialist job in Waller, TX
The Quality Auditor is responsible for all aspects of the internal quality systems audit program, including, but not limited to: audit planning, execution, follow-up and re-audit, if necessary. Maintaining audit systems and information management. QA auditor reviews protocols, qualification, and validation procedures documented by the organization. The QA Auditor is expected to follow the procedures and drive consistency of criterion and auditing best practices across the organization. If a manufactured product does not meet quality specifications, the QA Auditor investigates and reports the findings. The Quality Auditor is results and compliant orientated, has a dedication to excellence and sense of urgency to achieve business objectives.
Position Responsibilities may include:
* Audit the Fabrication and Assembly areas for ISO compliance by conducting Process and Product Audits
* Document Non-Conformances
* Collaborate with the production departments to identify root causes and implement corrective actions
* Review engineering BOM and drawings and provide feedback
* Assist Quality leadership in continuous improvement projects as assigned
* Document and maintain technical reports and complete all required documentation timely and accurately
* Bring to the Managers attention, any ideas or opportunities for CIP or QIP
* Follow all safety procedures including wearing appropriate PPE when required
* Perform additional projects/duties to support ongoing business needs.
Nature & Scope:
* Possesses a broad theoretical job knowledge typically obtained through advanced education.
* Has no discretion to deviate from established procedures by performing structured work assignments.
* Work is closely supervised.
* Problems faced are not typically difficult or complex.
* Explains facts, policies, and practices related to the job area.
Knowledge & Skills:
* Working knowledge of MS Office - Outlook, Excel, and Word (Proficiency with MS Excel is preferred)
* Effective verbal and written communication skills
* Basic Knowledge on reading and following Bill of Material
* Basic knowledge on engineering drawing
* Basic knowledge on using handheld measuring tools
* Ability to work with MAPICS/AS400 and PowerLink is preferred
* Ability to apply good judgment, strong work ethic, and integrity on the job.
Competencies:
Experience:
* 1 year of quality experience
Education/Certification:
* High School diploma or GED
People Management: No
Physical Requirements / Work Environment:
* Must be able to perform essential responsibilities with or without reasonable accommodations
Reports To:
* SUPERVISOR, QUALITY
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.
QA Specialist III, Data Integrity
Quality assurance specialist job in College Station, TX
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 ***************.
**Job Locations** _US-TX-College Station_
**Posted Date** _4 months ago_ _(8/15/2025 11:23 AM)_
**_Requisition ID_** _2025-35369_
**_Category_** _Quality Assurance_
**_Company (Portal Searching)_** _FUJIFILM Biotechnologies_