Qc Manager, Chemistry

1 week ago

Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

Position OverviewThe Quality Control Chemistry Manager, under general supervision, will be responsible for planning, organizing, directing, and evaluating routine activities of the QC staff as well as overseeing all raw material testing and release for use in GMP production.
The Chemistry Manager will lead tech transfer activities of qualified analytical methods from designated donor laboratories.
The Chemistry Manager will play a pivotal role in selecting qualified personnel to staff the QC chemistry laboratory.Reports to: Director, QCWork Location: College Station, TXCompany OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us.
We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives.
Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.Job DescriptionPrimary Responsibilities:Manage the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.Coordinate and oversee QC analytical testing for GMP batch release and stability testing.Ensure QC equipment is maintained in a qualified GMP state.Prepare, review 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.Coordinate and oversee all raw material testing (internal and external) in adherence to approved material specifications.Serve as QC lead during project team meetings.Participate in client calls and meetings.Release raw materials from quarantine using SAP.Assist in developing and managing QC Chemistry budget.Review and approve data / reports during release & stability testing.Ensure laboratory compliance to established specifications and procedures.Report excursions/out of specifications results and conduct 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 investigators during internal and external inspections.Follow all established laboratory, regulatory, safety, and environmental procedures.Identify deviations and report possible preventative and corrective actions using Trackwise.Perform other duties as assigned.Qualifications:Master's degree with 5+ years of industry experience in a GMP/GxP, or a comparable federally regulated environment.Bachelor's degree with 7+ years industry experience in a GMP/GxP, or a comparable federally regulated environment.4+ years of supervisory or managerial experience.Chemistry or Biochemistry major preferred.Analytical laboratory experience in a GLP/GMP regulated environment is preferred.Experience in Systems, Applications and Products (SAP) software preferred.Experience in Trackwise Deviation Management software preferred.Sound understanding of analytical instrumentation and methodologies, such as chromatography, electrophoresis, and spectrophotometry.Operate as a team leader, coordinate staff scheduling and training.Ability to follow safety procedures outlined in the Chemical Hygiene Plan.Utilize SDS 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, Gemba, and Genki.Physical Requirements: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.Ability to sit for long periods to work on a computer.Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, dusts, and other hazardous materials.Ability to wear personal protective equipment including safety glasses, lab coat, and gloves.Attendance is mandatory.Join us
FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential.EEO InformationFujifilm 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 InformationIf 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 (979) 431-3500).
#J-18808-Ljbffr

  • QC Chemistry Laboratory Director

    7 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    **About the Role**The Quality Control Chemistry Manager will be responsible for leading the QC Chemistry Laboratory, which includes supervising the QC Chemistry Staff, overseeing QC analytical testing, and ensuring compliance with established specifications and procedures. The manager will work closely with other departments to continuously improve the...

  • Senior Chemistry Team Lead

    7 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    **Job Summary**We are seeking an experienced Quality Control Chemistry Manager to join our team at Fujifilm Diosynth Biotechnologies. The successful candidate will be responsible for managing the QC Chemistry Staff, overseeing QC analytical testing, and ensuring compliance with established specifications and procedures.Key Responsibilities:Develop and...

  • Quality Control Manager for Analytical Services

    7 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    **Job Overview**The Quality Control Chemistry Manager will oversee the planning, organization, and direction of routine activities of the QC staff. This includes coordinating all raw material testing and release for use in GMP production. The manager will lead tech transfer activities of qualified analytical methods from designated donor laboratories.The...

  • QC Stability Coordinator

    1 week ago

    Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time

    Job Overview:The QC Stability Coordinator III will oversee the Quality Control Testing of Stability programs, including developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data. This role requires frequent communication with Chemistry, Cell Biology, Microbiology, and Quality Assurance groups to coordinate...

  • QC Laboratory Specialist

    7 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Job Summary:We are seeking an experienced QC Laboratory Specialist to join our team at Fujifilm Diosynth Biotechnologies. This role involves performing quality control microbiological aspects of cGMP compliance and testing, as well as maintaining a clean and organized laboratory environment.Key Responsibilities:- Ensure the microbiological aspects of cGMP...

  • Qc Analyst Ii, Microbiology

    1 week ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Position OverviewThe Microbiologist II will be responsible for the QC microbiological aspects of cGMP compliance and testing at the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory.Reports to: Supervisor, MicrobiologyWork Location: College Station, TXCompany OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been...

  • GxP Compliance Coordinator

    1 week ago

    Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time

    Job Duties:The GxP Compliance Coordinator will assist in preparing QC metrics on a monthly basis and ensure testing occurs within specified windows. The coordinator will also work directly with Contract laboratories to coordinate and monitor testing and release schedules and attend daily briefings and update as needed.Key Responsibilities:Assist in preparing...

  • Quality Control Specialist

    1 week ago

    Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time

    Job Description:The Quality Control Specialist will be responsible for implementing a Quality Control Stability Program that meets the needs of our clients. The specialist will oversee the construction, maintenance, and execution of stability testing programs, including developing schedules of pull dates and generating summaries from...

  • Geotechnical Specialist

    6 days ago

    Hamilton, Waikato, New Zealand Oceanagold Corporation Full time

    About the Role: We are seeking a highly skilled Geotechnical Specialist to join our Technical Services team at Waihi. This is an exciting opportunity to contribute to the ramp-up of production and work in a stunning residential location with access to beautiful beaches and scenic views.Main Responsibilities:Complete geotechnical mapping and logging for...

  • Stability Testing Manager

    1 week ago

    Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time

    Position Summary:The Stability Testing Manager is responsible for overseeing the quality control testing of stability programs. This includes developing a schedule of pull dates, overseeing testing of each pull, and generating summaries from the data. The manager will also communicate with various departments to ensure successful program execution.Main...

  • Audit and Inspection Expert

    7 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance - Compliance Specialist II - Audit and Inspection to join our team at FUJIFILM Diosynth Biotechnologies.The successful candidate will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.This...

  • GMP Quality Assurance Professional

    7 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Key ResponsibilitiesThe successful candidate will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.This includes working collaboratively with site management to instill a 'Quality Culture' by coaching in the application of GMP Principles, mentoring...

  • GMP Manufacturing Operations Manager

    5 days ago

    Hamilton, Waikato, New Zealand FUJIFILM Holdings America Corporation Full time

    Qualifications and ExperienceTo be successful in this role, you will require:A Bachelor's degree in a relevant field (e.g., biology, chemistry, engineering) or equivalent experience.At least two years of experience in biopharmaceutical manufacturing (GLP or GMP) or supply chain operations.Excellent communication, interpersonal, and organizational...

  • Senior Qa Analyst

    1 week ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Position OverviewThe Senior Quality Assurance (QA) Analyst, 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,...

  • Quality Assurance-Compliance Specialist Ii-Audit And Inspection

    1 week ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Position OverviewThe Quality Assurance - Compliance Specialist II - Audit and Inspection will support all associated responsibilities in compliance with FUJIFILM Diosynth Biotechnologies quality policies and site SOPs to ensure regulatory compliance.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are...

  • Senior Geotechnical Specialist

    6 days ago

    Hamilton, Waikato, New Zealand Oceanagold Corporation Full time

    OceanaGold is a growing intermediate gold and copper producer committed to safely and responsibly maximizing the generation of Free Cash Flow from our operations and delivering strong returns for our stakeholders.About Our OperationsWe have a portfolio of four operating mines: the Haile Gold Mine in the United States, Didipio Mine in the Philippines, and the...

  • Assistant Scientist- Downstream Process Development

    4 days ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Position OverviewSummary: The Assistant Scientist - Process Development is an entry-level position for graduates with no prior experience or training.The individual will assist in the development and characterization of customer programs and technology transfer to the manufacturing and/or Quality control group as appropriate.This individual will be expected...

  • Engineer - Geotechnical

    7 days ago

    Hamilton, Waikato, New Zealand Oceanagold Corporation Full time

    OceanaGold is a growing intermediate gold and copper producer committed to safely and responsibly maximizing the generation of Free Cash Flow from our operations and delivering strong returns for our shareholders.We have a portfolio of four operating mines: the Haile Gold Mine in the United States of America; Didipio Mine in the Philippines; and the Macraes...

  • Downstream Manufacturing Technician Iii

    1 week ago

    Hamilton, Waikato, New Zealand Fujifilm Holdings America Corporation Full time

    Position OverviewThe Manufacturing Technician III will work directly with a range of technologies.Company OverviewThe work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us.We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven...

  • Laboratory Supervisor

    3 days ago

    Hamilton, Waikato, New Zealand Ixom Full time

    Job description:About your roleWe are currently hiring for a Laboratory Supervisor based at our Morrinsville manufacturing site.Working within a stable, multi-disciplinary team and reporting to the Quality Services Manager, you will be responsible for providing and influencing the required technical, quality assurance, and process support to the business to...