Rockville, Maryland, United States · On-site
$100k–$133k/yr
Samsung Biologics is seeking an Auditor to support our Rockville, MD site. This role is responsible for managing internal audit programs and external supplier audits, while ensuring compliance with cGMP standards and reg…
Skills: Internal Auditing, Supplier Auditing, cGMP Compliance, CAPA Management, Regulatory Compliance
Rockville, Maryland, United States · On-site
$111k–$147k/yr
Samsung Biologics is seeking a highly skilled and motivated Senior Instruments & Controls (I&C) Engineer to join our biopharmaceutical manufacturing site in Rockville, Maryland. The ideal candidate will have a minimum of…
Skills: Instrumentation & Controls, cGMP, Troubleshooting, Calibration, Loop Tuning
Rockville, Maryland, United States · On-site
$83k–$110k/yr
Samsung Biologics is looking for QC Chemist who is responsible for performing quality sampling, aliquoting, shipping, testing and data review for raw materials under cGMP conditions. The role will support the manufacturi…
Skills: Quality Control, cGMP, Compendial Testing, SAP, Data Review
Rockville, Maryland, United States · On-site
$67k–$89k/yr
Samsung Biologics is seeking a QC Bioanalytical Senior Associate Analyst to perform cell-based bioassays and immunoassays in support of testing biopharmaceutical raw materials, in-process samples, and drug substance unde…
Skills: ELISA, SDS-PAGE, Western Blot, qPCR, cIEF
Rockville, Maryland, United States · On-site
$113k–$151k/yr
The Maintenance Planning & CMMS Manager is responsible for leading maintenance planning, scheduling, and CMMS administration to support safe, reliable, and compliant operations. This position serves as the site subject m…
Skills: Maintenance Planning, Scheduling, CMMS Administration, SAP PM, IBM Maximo
Rockville, Maryland, United States · On-site
$90k–$119k/yr
Samsung Biologics is looking for a Supply Chain & Procurement Manager to be responsible for coordinating procurement and supply chain activities across New Product Introduction (NPI) and commercial manufacturing programs…
Skills: Procurement, Supply Chain Management, Project Management, GMP Compliance, Strategic Sourcing
Rockville, Maryland, United States · On-site
Senior Biopharmaceutical Associate Qualifications: 3+ years of relevant manufacturing or bioprocessing experience Key Responsibilities: Independently execute manufacturing processes with minimal supervisionLead troublesh…
Skills: Biopharmaceutical Manufacturing, CDMO Services, Biologics Development
Rockville, Maryland, United States · On-site
Exemplify Samsung’s Culture—demonstrating ambition for patients, accountability for impact, and integrity—in every interaction, task, and responsibility associated with the role. Consistently embody these values to pro…
Skills: Documentation, Data Integrity, Manufacturing Execution, Troubleshooting, SAP
Rockville, Maryland, United States · On-site
$161k–$216k/yr
As a member of the Site Leadership Team (SLT) this role has accountability for oversight of bulk drug substance delivery to the customer network, inclusive of storing and shipping bulk drug and managing the supply chain …
Skills: Supply Chain Management, Logistics, GMP Compliance, S&OP, Resource Allocation
Rockville, Maryland, United States · On-site
$93k–$124k/yr
Samsung Biologics is seeking an experienced Electrical Engineer to support a commercial biopharmaceutical manufacturing site operating under GMP and applicable electrical standards in Rockville, MD. This role serves as a…
Skills: Electrical Engineering, GMP, NEC Codes, Root Cause Analysis, Project Management
Rockville, Maryland, United States · On-site
$23/hr–$31/hr
Samsung Biologics is looking for a Materials Technician to join the team. This role is responsible for performing manual and administrative duties related to the receiving, inspection, storage, issuance, and distribution…
Skills: Material Handling, Forklift Operation, SAP, cGMP Compliance, Inventory Control
Rockville, Maryland, United States · On-site
Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations. Perform the set-up, operation, cleaning and break-down of pro…
Skills: Media Preparation, Sterilization, Filtration, Cell Culture, Purification Operations
Rockville, Maryland, United States · On-site
$102k–$136k/yr
Samsung Biologics is looking for a QC Microbiologist who will be responsible for performing microbiological testing in support of GMP manufacturing operations, ensuring compliance with regulatory requirements and company…
Skills: QC Microbiology, GMP Compliance, Environmental Monitoring, Laboratory Management, Method Validation
Rockville, Maryland, United States · On-site
Skills: Biopharmaceutical Manufacturing, CDMO Services, Biologics Development
Rockville, Maryland, United States · On-site
Skills: Biopharmaceutical Manufacturing, CDMO Services, Biologics Development
Rockville, Maryland, United States · On-site
Skills: Biopharmaceutical Manufacturing, CDMO Services, Biologics Development
Rockville, Maryland, United States · On-site
Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations. Perform the set-up, operation, cleaning and break-down of pro…
Skills: Media Preparation, Sterilization, Filtration, Cell Culture, Purification Operations
Rockville, Maryland, United States · On-site
Preparation, cleaning, sterilization, batching, pasteurization or filtration and delivery of media and solutions for cell culture and purification operations. Perform the set-up, operation, cleaning and break-down of pro…
Skills: Media Preparation, Sterilization, Pasteurization, Filtration, CIP Skids
Rockville, Maryland, United States · On-site
$83k–$111k/yr
Join Samsung Biologics’ biopharmaceutical manufacturing site in Rockville, as an Analytical Systems Specialist. Essential functions include performing administration duties for analytical systems within Quality Control, …
Skills: Analytical Systems Administration, GxP Compliance, Data Integrity Assessment, Technical Troubleshooting, System Validation
Rockville, Maryland, United States · On-site
$130k–$140k/yr
The Human Resources Business Partner will play a pivotal role in the delivery of key HR initiatives which support the business strategy and improves business performance. The Human Resources Business Partner will coach b…
Skills: Organizational skills, Communication skills, Process excellence, Continuous improvement, Data analytics
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Manage internal and external supplier audit programs to ensure compliance with cGMP standards and regulatory requirements. Coordinate CAPAs, track audit commitments, and provide guidance to site personnel on regulatory expectations.
Requires a Bachelor's degree in a scientific discipline such as Biology or Chemistry. Candidates must have experience in a cGMP-regulated environment and strong knowledge of auditing practices and FDA expectations.
Samsung Biologics is seeking an Auditor to support our Rockville, MD site. This role is responsible for managing internal audit programs and external supplier audits, while ensuring compliance with cGMP standards and regulatory requirements.
Serve as an auditor for site internal audits and supplier audits.
Develop and maintain the annual audit plan, including facilitating periodic review meetings with management.
Conduct audit close-out meetings to communicate findings and expectations to stakeholders.
Prepare, issue, and maintain internal and supplier audit reports using standardized formats.
Review audit responses for adequacy, identify gaps, and work with owners to resolve discrepancies.
Coordinate and track CAPAs (Corrective Actions) associated with audit findings to ensure timely completion.
Monitor audit commitments and ensure adherence to established response timelines.
Generate and distribute monthly reports on outstanding audit commitments and CAPA status.
Perform follow-up activities to verify implementation and effectiveness of corrective actions.
Provide guidance to site personnel on cGMP compliance and regulatory expectations.
Support preparation for regulatory inspections, corporate audits, and customer audits.
Assist with audit observation follow-up related to regulatory inspections and global quality audits.
Interpret and communicate current regulatory requirements and industry guidance to internal stakeholders.
Collect, analyze, and report site Quality metrics and support quality trending activities within required timelines.
Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field)
Experience in a cGMP-regulated environment (biopharmaceutical industry preferred)
Strong knowledge of auditing practices and CAPA management
Familiarity with FDA and global regulatory expectations
The anticipated salary range for this position in Maryland is $99,825 to $133,100 plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
Benefits:
· 13 paid holidays
· Vacation time
· 401K match
· Medical, dental and vision benefits effective day one of employment
Innovation, passion and an unwavering dedication to find breakthrough solutions in biomedicines.
Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.
Offices: 300 Songdo Bio Way, Songdo, Incheon 21987, KR · 600 Gateway Blvd, San Francisco, California 94080, US · 100 Challenger Rd, New Jersey, New Jersey 07660, US · 260 Franklin St, Boston, Massachusetts 02110, US · Tokyo, Tokyo 102-0071, JP
View all jobs at Samsung BiologicsInnovation, passion and an unwavering dedication to find breakthrough solutions in biomedicines.
Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.
Offices: 300 Songdo Bio Way, Songdo, Incheon 21987, KR · 600 Gateway Blvd, San Francisco, California 94080, US · 100 Challenger Rd, New Jersey, New Jersey 07660, US · 260 Franklin St, Boston, Massachusetts 02110, US · Tokyo, Tokyo 102-0071, JP
View all jobs at Samsung Biologics