Analyst 1, QC Compendial Testing

Merck & Co.; Holly Springs (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking an Analyst 1 for QC Compendial Testing to ensure GMP-compliant operations per USP/EP/JP. You will participate in technology transfer of methods into the NC Quality Control Laboratory and perform testing and disposition of materials using established analytical methods.

The role requires a Bachelor’s degree in a relevant science with 0-1 years of industry experience, with opportunities to advance to master’s-level qualifications and

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry or related science with 0-1 years of industry experience.
• Basic understanding of GMP, GLP, GDP requirements.
• Master’s degree preferred in related field.
• Experience with compendial testing methodologies (cGMP) is a plus.
• Experience with assay troubleshooting and problem solving is a plus.

Responsibilities

• Support material life cycle management under supervision.
• Support QC Compendial Testing team in TT meetings for new products.
• Assist in implementing new technologies.
• Perform testing and disposition of incoming materials according to specs.
• Handle change controls and vendor change notifications.
• Initiate TrackWise deviations and CAPAs; manage lab exceptions.
• Support investigations in Out-of-Spec results.
• Maintain laboratory systems to ensure data integrity.
• Follow policies and escalate improvement opportunities.
• Review new and updated specifications.
• Use MSDS to assess hazards and PPE requirements.
• Perform other duties as assigned.

Skills

Computer Proficiency

Problem Solving

Attention to Detail

Communication Skills

Team Collaboration

Fast-Paced Environment

Independent Work

Self-Driven

Education

Bachelor’s degree in Chemistry/ Biology/ Microbiology/ Biochemistry

Master’s degree in Biology/ Chemistry/ Biochemistry/ Microbiology

Tools

TrackWise

Job description

Position Overview

The Analyst 1, QC Compendial Testing ensures laboratory operations are good manufacturing practices (GMP)-compliant according to United States\\Europe\\Japan pharmacopeia (USP/EP/JP) regulations. The role participates in the Technology Transfer (TT) of established methods into the FUJIFILM Biotechnologies, North Carolina Quality Control Laboratory. Following TT activities, the position performs material testing and disposition using the established analytical methods.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do

• Supports material life cycle management (new material assessment, specification establishment, maintenance of specifications etc.) under supervision.
• Supports QC Compendial Testing team on internal TT meetings related to new products.
• Assists the QC Manager in the implementation of new technologies.
• Authors and reviews procedures, protocols, reports and specifications related to compendial testing of materials under supervision and support.
• Performs testing and disposition of incoming raw materials and components according to specifications and procedures; adheres to predefined turnaround times.
• Executes actions related to change controls and vendor change notifications from partners or driven by internal or compendial needs.
• Initiates and implements TrackWise deviations and invalid assays, corrective and preventative actions (CAPAs); executes lab exceptions.
• Performs routine investigations in support of Out-of-Specification testing results.
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results.
• Follows established policies and procedures and escalates to management areas where enhancements will improve daily work.
• Reviews new and updated specifications.
• Utilizes Material Safety Data Sheets to properly assess chemical hazards, spill response procedures, and personal protective equipment (PPE) requirements, if indicated.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Computer proficiency.
• Effective problem-solving skills.
• Results-oriented and strong interpersonal skills.
• Ability to work in a fast-paced environment.
• Excellent attention to detail.
• Excellent verbal and written communication skills.
• Ability to complete tasks independently and with guidance/supervision.
• Self-driven, flexible and champions a collaborative attitude for the team.

Minimum Qualifications

• Bachelor's degree in Chemistry, Biology, Microbiology, Biochemistry or related scientific discipline with 0-1 years of applicable industry experience.
• Basic understanding of GMP, GLP, GDP requirements.

Preferred Qualifications

• Master's degree in Biology, Chemistry Biochemistry, Microbiology or other relevant scientific discipline with 0+ years of experience.
• 1-3 years relevant experience.
• Familiar with compendial testing methodology as it pertains to cGMP.
• Experience in assay troubleshooting and problem solving.
• Experience in a GMP environment.

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 essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Ability ot discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time for up to 240 minutes.
• Ability to sit for prolonged periods of time for up to 240 minutes.
• Ability to conduct activities using repetitive motions that include wrists, 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.
• Will work in warm/cold environments.
• Will work in small and/or enclosed spaces.

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 ([e-mail]).