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- Quality Assurance Specialist IVJob ID: req4712Employee Type: exempt full-timeDivision... ..., engineering standards, regulatory requirements, safety... ...Establish and maintain quality control processes to ensure... ...maintain quality-related documentation, including procedures, standards...RegulatoryFull timePart time
$39 per hour
...needs, we are looking for a Quality Control Research Associate - II.... ...QC Compliance & Data Review Specialist III (Contract) to join the... ...approvals, and supporting documentation; identify risks to timely closure... ..., internal audits, regulatory inspections, and responses...RegulatoryContract workTemporary workWork at officeShift work$80.33k - $103.95k
...Knowledge: Demonstrates advanced knowledge of Document Control fundamentals Quality Systems and GMP requirements. Demonstrates general knowledge... ...changes. Provides support with internal and regulatory audits/inspections as required. Provides user training...RegulatoryFull timeFor contractorsWork at officeLocal area$109.48k - $141.68k
...Sr Quality Assurance Specialist Everyone at Kite is grounded by one common goal... ...Manufacturing, Quality Control, Materials Management and... ...manufacturing and testing documentation for timely delivery of final... ...with Kite specifications, regulatory and GMP guidelines. Support...RegulatoryWork at officeLocal areaShift work- ...Clinical Materials Program in Frederick, MD. The role involves QA testing, calibration of critical equipment, and maintaining regulatory documentation in RAM/asset management systems. Responsibilities include preparing calibration records, SOP updates, and training staff...Regulatory
- ...ensures laboratory compliance with regulatory requirements, maintains laboratory... ...and calibration, manages documentation and records, supports quality assurance initiatives, and serves... ...files and ensure proper document control practices. Support onboarding and...RegulatoryWork at officeLocal areaRemote workMonday to Friday
$76.8k - $110.1k
...conformance to established quality assurance processes... ...of internal controls, communications, risk... ...assessments and maintenance of documentation as related to... ...safety, quality, and regulatory standards. Identifies... ...Training Calibration Specialist I/II on Calibration principles...RegulatoryFull timePart timeWork at office- ...support across manufacturing, utilities, quality control, and laboratory operations. The... ...cybersecurity, data integrity, and ongoing regulatory readiness in accordance with GMP, 21... .... Develop and update technical documentation, including SOPs, specifications, and work...RegulatoryFull timeRemote work
- ...with administrative processes. Prepares documents IAW regulation and policy; review and... ...ETMS-2, LINCS, and EDMS, ensuring document control and providing system access to qualified... ...and train personnel in support of regulatory requirements; and assists with presentations...RegulatoryContract workFor contractorsWork at officeLocal area
- ...Assess engagement in External Quality Assurance (EQA) programs *... ...efforts * Establish QA/QC documentation procedures and monitor QA/QC... ...and select appropriate regulatory and scientific resource material... ...science/research Quality Control or Quality Assurance clinical...RegulatoryFor subcontractorWork at office
$159.43k
...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- ...Protection Scientist supporting the Office of Research and Regulatory Compliance (ORRC), Office of Human Research Oversight (OHRO) at... ...oversight of DHA-supported research protocols through timely documented reviews of protocol lifecycle actions to ensure ongoing compliance...RegulatoryWork at officeLocal areaRemote work
$30.07 per hour
Aptask Global Workforce (AGW) is seeking a Quality Control Analyst for an Onsite position with a... ...review of test data and related documents for in-process testing, drug substance... ...procedures, methods, and submissions to regulatory agencies, as appropriate Gather metric...RegulatoryHourly payContract workFor contractorsMonday to FridayShift work- ...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
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$24.27 - $33.99 per hour
...adheres to the FH Compliance Program, including following all regulatory requirements and the FH Standards of Behavior. The... ...as patient specimens. Adheres to the laboratory’s quality control policies, document all quality control activities, instrument and procedural...RegulatoryHourly payFull timeTemporary workPart timeImmediate startShift workNight shiftRotating shift- ...wastewater treatment and disposal, regulatory compliance, system... ...Council Assist with drafting bid documents, reviewing proposals, and recommending... ...and Cross-connection Control Provide comprehensive... ...measures Extensive knowledge of quality control and quality assurance...RegulatoryFull timeContract workWork experience placementWork at officeLocal areaRemote workMonday to FridayFlexible hoursNight shift
$21 - $26 per hour
...Key Responsibilities Timely and accurately complete state regulatory surplus lines tax filings Ensure proper documents are received and reviewed from client submission Conduct compliance and quality review on documents, state legislation, codes and procedures...RegulatoryFull timeRemote work- ...compliance, operational implementation, and risk mitigation Experience supporting incident response, breach notification, and regulatory investigations Familiarity with privacy due diligence and data-related concerns in M&A and commercial transactions...RegulatoryFlexible hours
- ...fulfillment in a fast-paced central fill environment. You will ensure data accuracy and regulatory compliance while stocking and rotating medications and maintaining documentation. The role supports automated counting devices, reports on inventory, and adherence to policies...Regulatory
- Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to oversee regulatory documentation, IND activities, and clinical protocol coordination. The role requires collaboration with IPTs and stakeholders, ensuring compliance with FDA regulations and DoD acquisition...Regulatory
- ...sponsored research complies with Federal, DoD, FDA, and international requirements. The candidate will review protocols, identify regulatory deficiencies, and advise investigators and administrators. Hybrid work, strong regulatory expertise, and 9-5 core hours are...Regulatory
- Pace Analytical Services, LLC is seeking a senior CMC/regulatory affairs professional to lead and execute global regulatory... ...INDs, IMPDs, CTAs, and filings. The role emphasizes high-quality submissions, documentation, and effective communication with FDA, EMA, PMDA, and...Regulatory
- ...readiness and multi-omics research support. You will manage daily genomic operations, training, and supply chains while maintaining regulatory compliance. You will lead NGS workflows on Illumina and Oxford Nanopore platforms, supervise personnel, and coordinate with...Regulatory
- ...QC Compliance & Data Review Specialist III (Contract) Frederick, MD... ...Review Specialist to support quality operations in a GMP-... ...including deviations, CAPAs, change controls, and laboratory... ...compliance with cGMP, Good Documentation Practices, and FDA regulations...Full timeContract workMonday to Friday
- Tonix Pharmaceuticals is seeking a Senior Director, Regulatory Affairs for Infectious Disease to lead global regulatory strategy from early development through product registration. This senior role requires strategic thinking, strong FDA experience, and the ability to...RegulatoryWorldwide
- ...Civilian Human Resources Agency is seeking a Human Resources Specialist (Developmental) NF-03/04 to provide full HR services to managers... ..., training, benefits, and labor relations, with emphasis on regulatory compliance and advisory support. Qualifications include 6-18 months...RegulatoryWork at office
- ...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
- Advanced Group is seeking a Quality Control Analyst to support analytical testing and quality operations in a regulated manufacturing environment... ...data, and assist with investigations to ensure quality and regulatory compliance. The role requires a scientific bachelor's degree...Regulatory
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