Regulatory Document Control & Quality Specialist
CICONIX, LLC
CICONIX LLC is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities (ORA) in Fort Detrick, MD. The role will prepare, publish, and submit documents in accordance with applicable laws and guidance for drug, biologic, device, and combination products. The Specialist will provide document control and archiving support for electronic and paper records, and offer publishing, submission, and document control expertise to ORA and external partners. #J-18808-Ljbffr CICONIX, LLC
$55k - $58k
Document Control and Quality Specialist About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical... ...Role: Prepare documents for publishing and submission to regulatory agencies in the required formats, including electronic...RegulatoryFull timeFor contractorsWork at officeNight shiftWeekend work$22.44 - $30.36 per hour
...Quality Systems Associate Would you like to join an international team working to improve... ...QC and maintenance records. Documents, investigates, and performs root-cause analysis... ...ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include...RegulatoryHourly payWork at officeFlexible hours$83.2k - $124.8k
...Clinical Lab Information Specialist plays a critical role in... ...system validations, and regulatory compliance documentation. This position serves as... ...laboratory operations, IT, quality, and external vendors to... ...documentation within a highly controlled environment (e.g., CLIA,...RegulatoryLocal area$80.33k - $103.95k
...Quality Assurance SpecialistWe're here for one reason... ...a Quality Assurance Specialist. In this role you... ...identify and assess regulatory and quality risks in... ...labs.Ensure process control measures are in place... ...Review batch-related documentation and ensure resolution...RegulatoryTemporary workShift work- ...Maryland, is looking for a Delivery Lead to oversee testing and quality control processes. The ideal candidate has 2+ years in biotechnology... ...involves performing tests and maintaining compliance with regulatory requirements. Excellent communication and analytical skills...RegulatoryContract work
$130k - $200k
...to support case strategies and provide well-informed advice. Document Drafting: Prepare, review, and finalize contracts, pleadings,... ...strong presence in public sector law, advocating for clients in regulatory and legislative matters at all levels of government. Our services...RegulatoryLocal area- ...Job Title: Quality Analyst Location: 3275 Bennett Creek Avenue... ...(QA) assessments and control testing in adherence to the... ...and consistencyEnsure proper documentation and audit trails are maintainedPerformance... ...adherence to regulatory| compliance| and internal risk...Regulatory
- ...Safety, Engineering, or related field7+ years in manufacturing/industrial environments5+ years in safety leadership rolesStrong OSHA/regulatory expertise across multi‑site operationsProven ability to influence plant leadership and drive behavioral changeOSHA‑30 preferredIf...Regulatory
$76.44k
...implement, and maintain the project-specific Quality Assurance Surveillance Plan (QASP) in... ...• Perform daily quality inspections and document work progress to ensure materials,... ...Oversee construction contractor’s Quality Control meetings (Preparatory, Initial, and Follow...Contract workFor contractorsWork experience placementFor subcontractorH1bImmediate startFlexible hours$2,046 per week
...teams and families\n•\tMaintain compliance with all safety and regulatory standards\nQualifications:\n•\tGraduate of an accredited... ...Therapy program (MOT/OTD)\n•\tActive state OT license (or ability to obtain)\n•\tStrong clinical, documentation, and communication skills...RegulatoryFull timeContract workImmediate startShift work- ...Assess engagement in External Quality Assurance (EQA) programs... ...accreditation efforts Establish QA/QC documentation procedures and monitor QA/QC... ...and select appropriate regulatory and scientific resource... ...life science/research Quality Control or Quality Assurance...RegulatoryFor subcontractorWork at office
$2,046 per week
...Develop and update individualized treatment/discharge plans • Document services accurately and timely • Supervise COTAs per practice... ...teams and families • Maintain compliance with all safety and regulatory standards Qualifications: • Graduate of an accredited Occupational...RegulatoryFull timeContract workImmediate startShift work- CICONIX LLC is seeking a Regulatory Affairs Scientist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick... ...Product Profiles, managing risk registers, and coordinating regulatory documents in EDMS, with a full #J-18808-Ljbffr CICONIX, LLCRegulatoryWork at office
- CICONIX LLC in Fort Detrick, MD is seeking a Senior Regulatory Affairs Scientist to support the ORA for DHA R&D MRDC. The role focuses... ...submissions to CDER, CBER, and CDRH. You will serve as SME, coordinate document preparation in EDMS, interact with FDA, develop Target Product...Regulatory
$58.2k - $83.35k
...procedures according to approved SOPs and if applicable, regulatory requirements. Maintain complete, accurate, and... ...reagent records, and electronic databases. Perform routine quality-control activities and document assay performance, control results, deviations,...RegulatoryFull timePart timeWork at officeWorldwide$22.27 - $31.28 per hour
Quality Performance Education Specialist Job Category : Allied Health Requisition Number : QUALI012399 Posted... ...teams in development of electronic documentation solutions supporting workflows in... ...standing Sitting at keyboard/terminal/control console Working Conditions Blood...Hourly payFull timeTemporary workPart timeWork at officeImmediate startShift work- CICONIX, LLC, located in Fort Detrick, MD, is seeking a Senior Regulatory Affairs Scientist to support the Defense Health Agency and ensure compliance with FDA regulations. The ideal candidate will possess a RAC certification and have experience with regulatory strategy...RegulatoryFull time
- ROHDE & SCHWARZ GmbH & Co. KG is seeking a dedicated Quality Assurance Manager in Frederick, Maryland. The role involves developing,... ...quality management systems. You will be the primary contact for regulatory bodies and will oversee corrective actions, conduct audits,...Regulatory
- ...requirements. The CRA will conduct site qualification, initiation, monitoring, and closeout visits, perform SDV, review consent documentation, and oversee regulatory binders. Travel CONUS/OCONUS is required to support audits and inspections. #J-18808-Ljbffr Venesco,-LLC-Regulatory
- CICONIX is seeking a full-time Regulatory Risk & Quality Manager at Fort Detrick, MD. This role supports the Office of Regulated Activities (ORA) and focuses on ensuring compliance with national and international regulations for medical products. Responsibilities include...RegulatoryFull timeWork at office
- General Dynamics - IT is seeking a Senior Human Subjects Protection Scientist to support the Office of Research and Regulatory Compliance at Defense Health Agency Research & Development. In this role, you will provide regulatory-based reviews of protocols, ensuring compliance...RegulatoryWork at office
- ...aligning customer needs with suitable programs. You will analyze income, assets, and credit data while ensuring SAFE Act compliance and regulatory adherence. Responsibilities include interviewing applicants, assessing creditworthiness, and marketing bank mortgage products to...RegulatoryPermanent employment
- ...and closeout visits.Perform source data verification (SDV).Review informed consent documentation and study records.Evaluate protocol compliance and identify deviations.Review regulatory binders and essential documents.Generate clinical monitoring reports and follow-up...Regulatory
- ...Site Head of Precision for Medicine, onsite in Frederick, MD, to oversee three laboratory groups, optimize processes, and ensure regulatory compliance. You will translate FDA guidance into robust, passing assays, shaping GLP/GCP/GCLP programs and QC systems across Bioanalysis...Regulatory
- ...care services for residents. This leadership role emphasizes maintaining high care standards and ensuring regulatory compliance while promoting residents' quality of life. The ideal candidate will be a licensed RN with strong leadership and communication skills, coupled...Regulatory
- ...laboratories. The role guides daily genomic, biosurveillance, and systems biology operations, supports NGS workflows, maintains regulatory compliance, trains personnel, coordinates equipment and supply chains, and supports investigators in sequencing protocols for DoD...Regulatory
- ...Executive Director / Site Head of Precision for Medicine to oversee three laboratories in Frederick, MD, ensuring scientific excellence, regulatory compliance, and efficient operations. The role demands deep experience in GLP/GCP/GCLP, CAP/CLIA, and interaction with QA and...Regulatory
- ...across Bioanalysis, Flow Cytometry, and CDx. The role drives regulatory compliance and scientific excellence while ensuring operational... ...possess deep knowledge of FDA guidance, ISO 13485/15189 design controls, and CLIA/CLS I validation, with hands-on leadership to mentor...Regulatory
- ...Manager to lead 24x7 operations of one or more data center buildings. You will supervise technicians, ensure safety, reliability, and regulatory compliance while coordinating maintenance and vendor activities. The role requires strong leadership, experience in data center...Regulatory
- ...handling of freight shipments. Ensure proper documentation, labeling, and packaging of goods in... ...of customer concerns. Implement quality control measures to ensure accuracy and integrity... ...of freight handling processes and regulatory requirements. Proficiency in using warehouse...Regulatory
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