Analyst, Quality Control Sample Control (Friday to Monday)

Merck & Co.; Holly Springs (NC); On-site; USD 52,000 - 78,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC seeks a Quality Control Sample Control Analyst to ensure samples and reference materials are collected, stored, and documented in accordance with internal procedures. The role supports transport between facilities, prepares the Sample Management lab during projects, and maintains sample chain of custody with GMP documentation.

Responsibilities include handling QC samples, authoring procedures, and participating in continuous improvement projects to

Qualifications

• B.S./B.A. in relevant scientific discipline, preferably Chemistry
• Biochemistry, Microbiology, Biology or Life Sciences
• 0-3 years laboratory experience

Responsibilities

• Supports Sample Control team will provide sample collections 7 days a week when in Operations
• Supports Sample Control team to maintain and support equipment alarms during off hours and move samples as required, which may including routine on-call and weekend support, as needed
• Supports the setup of the Sample Management lab during Project phase including authoring procedures, sample collection in support of facility qualification, ordering lab supplies for QC department, logbook creation for QC, and additional activities, as needed
• Facilitates the movement of QC samples from Manufacturing to the QC labs maintaining sample chain of custody and GMP documentation
• Receives, inspects, and inventories reference materials and samples from external sources
• Documents sample receipt, storage, and movement by making entries into Labware LIMS and/or internal sample chain of custody forms or logbooks
• Collaborates cross-functionally to address sample issues that arise from manufacturing, laboratories, or the warehouse
• Assist in authoring SOPs, protocols and reports related to Sample Management
• Supports continuous improvement projects and SOP revisions by providing input into the process and supports associated procedural updates
• Maintains sample integrity in all aspects of working with samples and reference materials
• Performs other duties, as assigned.

Education

B.S./B.A. in relevant scientific discipline, preferably Chemistry

Biochemistry, Microbiology, Biology or Life Sciences

Job description

Position Overview

The Quality Control Sample Control Analyst works under the supervision and guidance from their manager to ensure all samples managed by the Sample Control team are handled and documented in accordance with applicable internal procedures. This role is responsible for handling samples manufactured at Fujifilm Biotechnologies and samples and reference materials from external sources. This role is primarily responsible for collecting and aliquoting samples. This role is also responsible for coordinating with key internal stakeholders the transport of QC samples from Fujifilm Biotechnologies to external testing laboratories and support continuous improvement projects and SOP revisions by providing input into the sample handling process. This role includes routine on-call and weekend support as needed.

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

Responsibilities:

• Supports Sample Control team will provide sample collections 7 days a week when in Operations
• Supports Sample Control team to maintain and support equipment alarms during off hours and move samples as required, which may including routine on-call and weekend support, as needed
• Supports the setup of the Sample Management lab during Project phase including authoring procedures, sample collection in support of facility qualification, ordering lab supplies for QC department, logbook creation for QC, and additional activities, as needed
• Facilitates the movement of QC samples from Manufacturing to the QC labs maintaining sample chain of custody and GMP documentation
• Receives, inspects, and inventories reference materials and samples from external sources
• Documents sample receipt, storage, and movement by making entries into Labware LIMS and/or internal sample chain of custody forms or logbooks
• Collaborates cross-functionally to address sample issues that arise from manufacturing, laboratories, or the warehouse
• Assist in authoring SOPs, protocols and reports related to Sample Management
• Supports continuous improvement projects and SOP revisions by providing input into the process and supports associated procedural updates
• Maintains sample integrity in all aspects of working with samples and reference materials
• Performs other duties, as assigned.

Education/Experience Requirements

• B.S./B.A. in relevant scientific discipline, preferably Chemistry,
• Biochemistry, Microbiology, Biology or Life Sciences
• 0-3 years laboratory experience
• Must be available to work weekends as part of your work schedule

Education/Experience Preferred

• GMP laboratory experience
• Experience with LIMS software

Physical Requirements & Environmental Conditions

• Ability to discern audio cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual activity, including distinguishing color
• Ability to stand for prolong periods of time up to 60 minutes
• Ability to sit for prolong periods of time up to 60 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
• Will work in small and/or enclosed spaces
• Will work in heights greater than 4 feet

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]).