Quality Control Raw Materials Chemist III

3 weeks ago

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

The Quality Control Raw Materials Chemist III, with limited supervision, will be responsible for participating in the Technology Transfer of established methods into the FUJIFILM Biotechnologies Diosynth Texas (FDBT) Quality Control Laboratory. Following Tech-Transfer Activities, the candidate will be responsible for performing in-process, release and stability testing using the established analytical methods.

Job Title: Quality Control Raw Materials Chemist III

Reports to: Quality Control Chemistry Manager

Job Description

Primary Responsibilities:

  • Function as SME for raw material release and chemical analysis of materials.
  • Collaborate and/or approve item specifications.
  • Assist with scheduling and coordination of raw materials sample, testing and release.
  • Assist with outsource lab testing audits; follow up for data and results reconciliation.
  • Assist with training and technical mentoring for technicians with less experience.
  • Prepare monthly metrics for raw material release. Maintain adequate inventory of supplies needed for all raw material sampling including but not limited to pipets, containers, and consumables.
  • Perform area cleaning and waste removal, as needed. Author, review and update SOPs as needed; understand and follow complex written procedures.
  • Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in Deviations and recommend possible corrective actions.
  • Maintain the safety and orderliness of the Retain Cage.
  • Reports excursion/out of specifications results to the QC Departmental Supervisor/Manager.
  • Provides OOS investigational support as needed.

Required Skills & Abilities:

  • Ability to analyze raw data, assess assay and system suitability criteria, understand process from beginning to end, and explain process.
  • Excellent communication skills.
  • Ability to work independently or in a team. Perform as a SME in the designated methods transferred into FDBT.
  • Previous pipetting experience.
  • 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.
  • Excellent attention to detail.
  • Computer proficiency required.
  • Excellent written and oral communication skills.
  • Excellent organization and analytical skills.

Minimum Qualifications:

  • Bachelor's degree in Chemistry, Biochemistry, or related degree with three (3) years hands-on laboratory experience; OR
  • Associates degree in Chemistry, Biochemistry, or related degree with five (5) years of hands-on laboratory experience;
  • AND 2 years' industry experience in a GMP / GxP or a comparable federally regulated environment.

Preferred Qualifications:

  • Familiar with monoclonal antibody testing methodology. Experience in assay troubleshooting and problem solving.

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 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.
  • Ability to lift up to 30 pounds on occasion.
  • Attendance is mandatory.

Join us FDB is advancing tomorrow's medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

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 (FDBTHR@fujifilm.com or (979) 431-3500).

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