Regulatory Compliance Specialist
15 hours ago
The Quality Assurance Specialist will play a vital role in ensuring the compliance of manufacturing operations with regulatory and industry standards. This position involves on-floor oversight to guarantee that processes adhere to quality standards.
Main Responsibilities:
• Conduct real-time documentation reviews of batch records, cleaning logs, and other documentation during the manufacturing process.
• Collaborate closely with manufacturing and support teams to troubleshoot issues and facilitate smooth operations.
• Perform Acceptable Quality Limit (AQL) inspections of drug products.
• Review and approve documentation related to media and buffer preparation.
• Create or update Standard Operating Procedures (SOPs) and review Master Batch Records.
• Compile and address deviations observed on the floor, ensuring timely resolution.
• Conduct audits of manufacturing and support areas to ensure adherence to internal procedures and Good Documentation Practices.
Requirements:
A degree in Engineering or Biotech field with 0-2 years of experience in QA/QC/Manufacturing within biologics, biopharmaceuticals, or a regulated industry. OR a Bachelor's degree in a Scientific, Engineering, or Biotech field with 2-4 years of experience in QA/QC/Manufacturing.
Skills:
Understanding of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, and 600s, ICH Guidelines, and EU GMPs. Familiarity with biological manufacturing processes, including cell banking, fermentation, purification, and fill/finish. Ability to apply scientific and regulatory principles to solve operational and quality-related challenges. Proficiency with electronic systems and software, including Microsoft products; experience with LIMS, Master Control, and Trackwise is a plus.
-
Regulatory Compliance Specialist
4 weeks ago
Reston, Virginia, United States Insight Global Full timeJob SummaryInsight Global is seeking an experienced Regulatory Specialist to provide permitting and regulatory compliance expertise to an upstream oil and gas client. The successful candidate will collaborate with technical, legal, and land teams to ensure compliance with state, federal, and transportation regulations.Key ResponsibilitiesAct as the subject...
-
Regulatory Compliance Specialist
3 weeks ago
Reston, Virginia, United States Insight Global Full timeJob SummaryInsight Global is seeking an experienced Regulatory Specialist to provide permitting and regulatory compliance expertise to an upstream oil and gas client. The successful candidate will collaborate with technical, legal, and land teams to ensure compliance with state, federal, and transportation regulations.Key ResponsibilitiesAct as the subject...
-
Regulatory Compliance Specialist
2 weeks ago
Reston, Virginia, United States Rare Beauty Full timeAbout the RoleRare Beauty is seeking a highly skilled Regulatory Specialist to join our Research and Development team. As a key member of our team, you will be responsible for ensuring the safety and regulatory compliance of our products, while also collaborating with internal teams and external partners to drive product development and innovation.Key...
-
Regulatory Compliance Expert
2 weeks ago
Reston, Virginia, United States Insight Global Full timeJob SummaryAn experienced Regulatory Specialist is sought by Insight Global to provide permitting and regulatory compliance expertise to an upstream oil and gas client. This role requires collaboration with technical/legal/land teams to input/support the permitting process for applications to the USCG, BSEE, BOEM, PHMSA, and USACE. The successful candidate...
-
Regulatory Compliance Specialist
2 weeks ago
Reston, Virginia, United States Kelly Science, Engineering, Technology & Telecom Full timeRegulatory Compliance RoleKelly Science & Clinical is seeking a skilled Regulatory Compliance Manager to join our team at a cutting-edge client in Orange, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, we'd love to hear from you.OverviewThis client is a premier private...
-
Regulatory Compliance Specialist
2 months ago
Reston, Virginia, United States Educational Federal Credit Union Full timeJob SummaryThe Compliance Analyst plays a critical role in ensuring Educational Federal Credit Union's adherence to all applicable regulatory requirements. This position coordinates compliance initiatives with other departments in accordance with business plans, tracks compliance management centrally, and serves as a liaison with various business units when...
-
Regulatory Compliance Specialist
2 weeks ago
Reston, Virginia, United States Collabera Full timeWe are seeking a highly skilled Regulatory Compliance Specialist to lead the review, approval, and audit readiness of software lifecycle (SLC) deliverables for regulated applications. This role requires close collaboration with cross-functional teams to ensure compliance with industry standards while meeting business needs.Key Responsibilities:Review and...
-
Senior Compliance and Regulatory Expert
2 weeks ago
Reston, Virginia, United States Planet Pharma Full timeJob Title: Senior Compliance and Regulatory SpecialistPlanet Pharma is seeking a highly skilled Senior Compliance and Regulatory Specialist to join our team. As a key member of our Clinical Development and Supply division, you will play a critical role in ensuring compliance with global regulations and standards.Key Responsibilities:Manage the supplier...
-
Regulatory Compliance Specialist
1 week ago
Reston, Virginia, United States Rare Beauty Full timeAbout Rare BeautyRare Beauty is a company that aims to break down unrealistic standards of perfection. We empower our team and community to challenge beauty norms by shaping positive conversations about self-acceptance and mental health. Our mission is to help everyone celebrate their individuality by redefining what beautiful means.Job SummaryThe Regulatory...
-
Regulatory Compliance Specialist
2 weeks ago
Reston, Virginia, United States Rare Beauty Full timeAbout Rare BeautyRare Beauty is a company that challenges beauty norms by promoting self-acceptance and mental health. We empower our team and community to create positive conversations about individuality and beauty standards. Our mission is to redefine what beautiful means and provide tools for self-acceptance.Job SummaryThe Regulatory Coordinator is a key...
-
Regulatory Compliance Specialist
1 month ago
Reston, Virginia, United States Rare Beauty Full timeAbout Rare BeautyRare Beauty is a company that empowers individuals to challenge beauty norms and promote self-acceptance. Our mission is to redefine what beautiful means by creating a community that celebrates individuality.Job SummaryThe Regulatory Coordinator will be part of the Research and Development team, responsible for ensuring product compliance...
-
Regulatory Compliance Specialist
1 month ago
Reston, Virginia, United States Rare Beauty Full timeAbout Rare BeautyRare Beauty is a company that empowers individuals to challenge beauty norms and promote self-acceptance. Our mission is to redefine what beautiful means by creating a community that celebrates individuality.Job SummaryThe Regulatory Coordinator will be part of the Research and Development team, responsible for ensuring product compliance...
-
Reston, Virginia, United States RIM Operating, Inc Full timeJob OverviewRIM Operating, Inc is seeking a detail-oriented and analytical Production Analyst/Regulatory Compliance Specialist to support operational efficiency, regulatory adherence, and continuous improvement efforts within our organization.Key ResponsibilitiesProduction AnalysisResponsible for all production-related functions, including:• Maintaining...
-
Regulatory Compliance Specialist
4 weeks ago
Reston, Virginia, United States EVONA Full timeRegulatory EngineerAt EVONA, we are seeking a highly skilled Regulatory Engineer to support our client's spectrum coordination efforts with federal and international entities. As a key member of our team, you will represent the company in ITU study groups, Regional Telecommunications Organizations, and other regulatory bodies, driving strategies to secure...
-
Regulatory Compliance Specialist
2 weeks ago
Reston, Virginia, United States EVONA Full timeRegulatory Engineer Role at EVONAAs a key member of our team, you will play a crucial part in supporting our client's spectrum coordination efforts with various federal and international entities. You will represent EVONA in ITU study groups, Regional Telecommunications Organizations, and other regulatory bodies, driving strategies to secure and optimize the...
-
Global Regulatory Compliance Specialist
2 weeks ago
Reston, Virginia, United States Power Dream Full timeAbout Power DreamPower Dream is a leading player in the global Energy Curing industry, specializing in oligomers, monomers, and additives. With over two decades of experience, we prioritize innovation, eco-friendliness, substance, and responsibility. Our goal is to introduce cutting-edge technologies to diverse markets including graphic arts, coatings, nail...
-
Regulatory Compliance Coordinator
3 days ago
Reston, Virginia, United States Northwest Asset Management Full timeJob SummaryThe Compliance Specialist plays a critical role in managing registration and regulatory compliance processes for SEC and state-registered firms. This position involves overseeing RIA registration processing, customizing Form ADV Parts 2A and 2B, and ensuring timely submission of annual renewal fees. This multifaceted role is essential for ensuring...
-
Senior Compliance and Regulatory Expert
1 week ago
Reston, Virginia, United States Planet Pharma Full timeThe Senior Regulatory and Compliance Specialist candidate must possess in-depth knowledge of global regulations pertinent to the pharmaceutical industry and their impact on manufacturing processes and practices. The ideal candidate must be agile, with well-developed organizational, interpersonal, compliance, and practical application skills. This individual...
-
Regulatory Compliance Manager
2 weeks ago
Reston, Virginia, United States MyFunded Futures Full timeRegulatory and Compliance ManagerCompany: MyFundedFuturesLocation: RemoteAbout Us:MyFundedFutures is a leading futures prop trading firm that empowers traders to monetize their market potential. We provide a platform for traders to demonstrate their skills, complete challenges, and receive allocated simulated funds to participate in the futures market...
-
Regulatory Affairs Specialist
3 weeks ago
Reston, Virginia, United States BioTalent Full timeJob Title: Senior Regulatory SpecialistLocation: Bay AreaCompany: BioTalent, a leading medical technology company, is seeking a highly skilled Senior Regulatory Specialist to join its team.Responsibilities:Develop and execute regulatory strategies for Class III medical devices, ensuring compliance with FDA regulations.Collaborate with cross-functional teams...