QC Chemist

Samsung Biologics•Rockville, MD

5d•$83,325 - $110,100•Onsite

About The Position

Samsung Biologics is looking for a QC Chemist responsible for performing quality sampling, aliquoting, shipping, testing, and data review for raw materials under cGMP conditions. This role supports manufacturing campaigns by ensuring raw materials testing is completed within established timelines. The role also supports the operation and maintenance of QC laboratory equipment/instruments to comply with cGMP regulations. The QC Chemist conducts and documents routine compendial (NF/USP/BP/EP/JP) and non-compendial raw material testing in a cGMP environment to support manufacturing. They serve as a qualified trainer with appropriate experience in performing routine raw material testing and train other team members. The position requires the ability to receive and process raw materials using SAP to assign testing requirements and ensure chain of custody of materials within the laboratory. The role involves seeking and accomplishing additional tasks such as aliquoting, sample shipments, laboratory inventory, reviewing and approving routine compendial test results documents, and other laboratory tasks, or non-routine functions according to written procedures in compliance with cGMP with general supervision. The individual will overcome minor conflicts with priorities and consult their supervisor with major conflicts. They will perform laboratory duties and safety checks following all safety, cGMP, CFR, and other regulations to assure laboratory compliance. As assigned, the QC Chemist participates in EHS team activities for Chemical Inventory, Risk Assessments, or other initiatives as assigned by management to ensure laboratory compliance. They will work with the manager to conduct laboratory investigations, deviations, and change controls related to raw material testing, and use SAP to manage on-site notifications (DE/LI/MC/CAPA) by adhering to timelines. The role involves evaluating laboratory SOPs and recommending improvement opportunities to maintain compliance with corporate and regulatory guidelines, and developing or revising laboratory SOPs as required. The ability to work effectively as part of a team and exhibit effective interpersonal skills within the group and with other groups within the department is essential. The QC Chemist will be trained as an L1 Auditor and participate in over 25% of the department’s L1 Inspections. They will maintain the laboratory according to EHS requirements and participate in continuous improvement programs such as GPS, ZAPs, ZIPs. The role includes participation in the on-call response team for chamber maintenance or ADHOC raw material testing.

Requirements

B.S. / B.A. degree in science field is required.
3+ years of relevant experiences in a pharmaceutical development or quality control environment.
1+ year of compendial testing experience.
2+ year of cGMP laboratory experience.

Nice To Haves

Chemistry is preferred

Responsibilities

Performing quality sampling, aliquoting, shipping, testing and data review for raw materials under cGMP conditions.
Supporting manufacturing campaigns by ensuring raw materials testing completion within established timelines.
Supporting operation and maintenance of QC laboratory equipment/instrument to comply with cGMP regulations.
Conducting and documenting routine compendial (NF/USP/BP/EP/JP) and non-compendial raw material testing, in cGMP environment to support manufacturing.
Serving as a qualified trainer with appropriate experience in performing routine raw material testing, trains other team members.
Receiving and processing raw materials using SAP to assign testing requirements and ensure chain of custody of materials within the laboratory.
Seeking additional tasks (aliquoting, sample shipments, laboratory inventory, reviews and approves routine compendial test results documents and other laboratory tasks) or non-routine functions and accomplishing them according to written procedures in compliance with cGMP with general supervision.
Overcoming minor conflicts with priorities and consulting supervisor with major conflicts of priorities.
Performing laboratory duties and safety checks following all safety, cGMP, CFR and other regulations to assure laboratory compliance.
Participating in EHS team for Chemical Inventory, Risk Assessments or other initiatives as assigned by management to ensure laboratory compliance.
Working with the manager to conduct laboratory investigations, deviations and change controls related to raw material testing.
Using SAP to manage notifications on-site (DE/LI/MC/CAPA) by adhering to timelines.
Evaluating laboratory SOPs and recommending improvement opportunities to maintain compliance with corporate and regulatory guidelines.
Developing or revising laboratory SOPs as required.
Working effectively as part of a team and exhibiting effective interpersonal skills within the group as well as with other groups within the department.
Being trained as an L1 Auditor and participating in >25% of department’s L1 Inspections.
Maintaining the laboratory according to EHS requirements.
Participating in continuous improvement programs such as GPS, ZAPs, ZIPs.
Participating in the on-call response team for chamber maintenance or ADHOC raw material testing.