Sr. Analyst I, QC Raw Materials

Overview

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business.

This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services.

The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The QC Raw Materials Sr. Analyst 1 is accountable for GMP compliant laboratory operations according to USP / EP / JP regulations.

The role will be responsible for participating in the Technology Transfer of established methods into the FDBN Quality Control Laboratory.

Following Tech-Transfer Activities, the position will be responsible for performing raw material testing and disposition using the established analytical methods.

• Under supervision, support raw material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.)
• Supports QC Raw Materials team on internal tech transfer meetings related to new products.
• Under supervision and support, authors and reviews procedures, protocols, reports, and specifications related to the raw material area.
• Performs testing and disposition of incoming raw materials and components according to specifications and procedures.
• Assesses and executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Responsible for initiation and execution of Trackwise deviations, CAPA's, lab exceptions and invalid assays
• Authors and implements corrective and preventative actions from approved deviations, CAPA's, lab exceptions and invalid assays in Trackwise.
• Performs routine investigations in support of out of specification testing results.
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
• Enforces established policies and procedures and escalates to management areas where enhancements will improve daily work.
• Assists Manager, QC in the implementation of new technologies.
• Adheres to pre-defined turnaround times of raw material testing.
• Reviews new and updated specifications
• Assesses lab exceptions and performs routine investigations.
• Utilizes MSDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated
• Performs other duties, as assigned

External US

Minimum Requirements

• B.A. / B.S. degree in Chemistry, Biology, Microbiology, Biochemistry, or other relevant scientific discipline
• 3 years relevant experience
• Previous experience in a GMP environment
• Computer proficiency required.

Preferred Requirements

• Masters degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years experience
• Familiar with Raw Material methodology as it pertains to cGMP
• Experience in assay troubleshooting and problem solving.

PHYSICAL DEMANDS

• Ability to stand for prolonged periods of time up to 240 minutes
• Ability to sit for prolonged periods of time up to 240 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and / or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18 to 60 in height, and use twisting motions.

ENVIRONMENTAL CONDITIONS

Will work in warm / cold environments 5C Range

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed, please email .

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.

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