Quality Control Chemist - Raw Materials
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 28, 2023
Overview Follow Your Genki to FUJIFILM Diosynth Biotechnologies
(FDB) The work we do at FDB 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. We are proud to
cultivate a culture that will fuel your passion, energy and drive -
what FDB call Genki.Summary: The QC Chemist - Raw Materials I,
under direct supervision, will be responsible for assisting with
raw material sampling, managing quarantine materials and prepare
sample shipments for contract laboratory testing. They will also
assist with supporting the Quality Control department in the
release of all raw materials from the Quarantine Cage/Area for use
in Non-GMP and GMP manufacturing activities for NCTM and
TBF-100.Other responsibilities may include but are not limited to:
Filing folders, Managing SAP for material accountability at TBF-100
and at NCTM, ordering materials for sampling, coordinating with
Materials Management/Warehouse Department on release of components
and chemicals, and acquiring BSE/TSE, OAF, USP Class VI statements
and/or applicable documents from vendors. External US Essential
- Assist with raw material release.
- Helps prepare monthly metrics for raw material release as
- Assist with sample and release of materials as needed.
- Assist with wet chemical analysis of material as needed.
- Maintain adequate inventory of supplies needed for all raw
material sampling including but not limited to pipets, containers,
- Transport and ship test samples and raw materials.
- Perform area cleaning and waste removal, as needed.
- May assist in authoring, reviewing and updating SOPs as needed;
understand and follow 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 Quarantine
- Reports excursion/out of specifications results to the QC
- Provides OOS investigational support as needed.
- Perform other duties as assigned. Required Skills & Abilities:
- Apply knowledge of cGMPs on a daily basis, as applicable.
- Follow all established laboratory, regulatory, safety, and
- Adhere to the standards of quality governed by current GMP's
and the company Quality Policies and site SOPs.
- Ability to multi-task and prioritize work assignments with
- Ability to accurately complete required documentation.
- Knowledge of MS Office (Word, Excel, Outlook).
- Ability to analyze raw data, assess assay and system
- Ability to follow safety procedures outlined in the Chemical
- Utilize MSDS sheets to properly assess chemical hazards, spill
response procedures, and PPE requirements if indicated.
- Excellent attention to detail.
- Ability to work in a team or independent setting and
collaborate with employees from various departments.
- Computer proficiency required.
- Excellent analytical skills.
- Must have excellent organizational, written communication and
oral communication skills. 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
- 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 work weekends and off-shift hours as needed to
support manufacturing activities.
- Attendance is mandatory.
- Ability to lift 20 - 30 lbs involving the movement of raw
materials within the quarantine cage. Minimum Qualifications:
- High School Diploma or GED with 2 years of experience; OR
- Associates degree Preferred Qualifications:
- Bachelor degree in science, supply chain, and/or related
- GMP/GLP experience
Keywords: FDBT - FUJIFILM Diosynth, College Station , Quality Control Chemist - Raw Materials, Professions , College Station, Texas
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