Regulatory Submissions QC Specialist
Creative Solutions Services, LLC
Creative Solutions Services, LLC is seeking a Quality Control (QC) professional in Port Reading, New Jersey. The role involves supporting regulatory submission activities by performing quality reviews of submission documents to ensure compliance with FDA, EU, and internal requirements. The ideal candidate will have over three years of experience in Regulatory Affairs, Document Control, or Quality, coupled with strong attention to detail and familiarity with submission publishing tools like Veeva and SharePoint. This position offers a dynamic work environment focused on compliance and quality. #J-18808-Ljbffr Creative Solutions Services, LLC
- Job Description Our Client is seeking a Quality Control (QC) professional to support regulatory submission activities by performing quality review of submission documents and ensuring completeness, accuracy, consistency, and compliance with applicable regulatory requirements...RegulatoryFor contractors
$117k - $184.2k
Overview The COA Sr. Specialist is responsible for end-to-end COA systems project management... ...processes (preferably through submission) Clinical data management Change management... ...management Project risk and issue management Regulatory compliance Stakeholder communications...RegulatoryFor contractorsWork experience placement- ...safe delivery to patients. You will execute testing, log blood products, and maintain operational standards while complying with regulatory policies. The preferred candidate will have a Bachelor’s Degree in Medical Technology, with ASCP certification being a plus. University...Regulatory
$106.2k - $167.2k
# Senior Specialist, Quality Assurance, Clinical QualityMerckRahway, NJFull-TimeJun 15, 2... ...while complying with applicable global regulatory requirements through sound processes, procedures... ...activities, clinical study reports and submission documents, and Country Offices (COs)...RegulatoryFor contractorsLocal areaRemote workRelocationVisa sponsorshipFlexible hours- Senior Cultural Heritage Specialist (Archaeologist/ Anthropologist) EOI Location: Perth Job type: Full Time ABOUT THE OPPORTUNITY About... ...Australia, including contemporary consultation frameworks and regulatory processes. Just as importantly, you will have experience...RegulatoryFull timeWork at officeRemote workRelocation packageFlexible hoursDay shift
- ...Reconciliation Specialist BizTek People is looking for a Reconciliation Specialist for our client in NJ! Schedule: Hybrid Summary:... ...understanding of relevant banking regulations, directing any regulatory questions to the Legal and Compliance Division, attending required...Regulatory
- ...Metrology Specialist I On-site in Rahway, NJ Summary: Manage equipment assets at multiple locations Gain a working knowledge... ...laboratory equipment during audits. Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures....Regulatory
$106.2k - $167.2k
...development life cycle. The QA Clinical Quality (CQ) team ensures the safety, rights, and well‑being of participants and compliance with regulatory requirements through sound processes and strategies. Primary Responsibilities Lead and prioritize own tasks to produce high‑...Regulatory$87.3k - $137.4k
Specialist - GMP Sample Repository Our company is currently seeking a Specialist with strong compliance skills to work in the GMP Sample... ...standards in accordance with SOPs, cGMPs, and federal and regulatory guidelines. Prepare and maintain accurate documentation associated...RegulatoryFor contractorsImmediate start- .... Our Construction Safety Professionals partner directly with General Contractors to implement effective safety programs, ensure regulatory compliance, and promote a proactive, site-wide safety culture. This role requires strong field presence, leadership capability, and...RegulatoryDaily paidFor contractorsFor subcontractorWork at officeFlexible hours
$25 - $28 per hour
...Order Entry Specialist A highly reputable manufacturing company is looking for a Customer Account Specialist to join their team! This... ...with all company policies, procedures, and applicable regulatory requirements. Support the organization in achieving established...RegulatoryContract workTemporary work- Katalyst CRO in Edison, NJ is seeking a qualified individual to lead publishing activities for regulatory submissions. The ideal candidate has a Bachelor’s or Master’s degree in Pharmacy or Life Sciences, with 5-10 years of experience in eCTD/NeeS publishing. Responsibilities...Regulatory
- ...Pharmaceutical Management, Pharmaceutical Microbiology, Pharmaceutical Sales Training, Pharmaceutical Sciences, Pharmacy Consulting, Regulatory Compliance, Sage Medical Manager, Sales Calls, Sales Metrics, Sales Pipeline Management, Sales Presentations, Sales Process...RegulatoryRelocationVisa sponsorshipFlexible hoursShift work
$96.2k - $151.4k
Senior Specialist, New Product Introductions Responsibilities Gather, create, deliver, track, analyze, model, and manage data for strategic... ...Procurement Management & Strategies Production Planning Regulatory Compliance Risk Assessment & Mitigation (REMS, Risk Management...RegulatoryContract workWork at office$117k - $184.2k
Job Description COA Sr. Specialist is responsible for providing end-to-end COA systems project management support, including gathering... ...Improvements Project Management Project Risk and Issue Management Regulatory Compliance Stakeholder Communications Third ‑Party Vendor...RegulatoryWork experience placementLocal area$106.2k - $167.2k
...across the Discovery, Preclinical, and Translational Medicine (DPTM) Ops portfolio — spanning capital asset life cycle management, regulatory and safety compliance, externalization, site operations, and lab support. This role strengthens our ability to operate in an...RegulatoryFull timeFor contractorsWork at officeLocal areaRelocationVisa sponsorshipFlexible hoursShift work$20.9 - $23.92 per hour
...for future generations. Role Summary As an Adventure Readiness Specialist, you are a critical part of the Rivian Service team during our... ...employment contract with you; (iv) complying with our legal, regulatory and corporate governance obligations; (v) recordkeeping; (vi)...RegulatoryHourly payFull timeContract workTemporary workPart timeSeasonal workLocal areaFlexible hoursShift work$96.2k - $151.4k
Senior Specialist, New Product Introductions Our company is a global healthcare leader with a diversified portfolio of prescription medicines... ...Management, Procurement Strategies, Production Planning, Regulatory Compliance, Risk Assessments, Risk Management, Strategic...RegulatoryContract workWork experience placementWork at officeRelocationShift work$106.2k - $167.2k
...compliant clinical supply distribution networks for assigned clinical studies with a focus on operational readiness, trade compliance, regulatory requirements, and depot preparedness to support global distribution. Responsibilities Analyze, design, and maintain compliant and...RegulatoryFor contractorsLocal areaWorldwideShift work$117k - $184.2k
...business needs into technical designs and integration workflows Ensure integration complies with organizational security standards, regulatory guidelines (GxP, HIPAA, SOX) and industry best practices Manage data flow governance and error handling mechanisms Monitor,...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- ...Myers Squibb is seeking a Manager for CMC Documentation & Specifications in New Brunswick, NJ. This role entails authoring CMC regulatory submissions, collaborating closely with various departments to ensure timely filings. The ideal candidate will have a degree in a...RegulatoryFlexible hours
- ...is seeking a Manager for CMC Documentation in New Brunswick, NJ. The role involves compiling and authoring CMC sections of regulatory submissions, coordinating with various teams to ensure timely document delivery. Ideal candidates will have a degree in organic chemistry...RegulatoryFlexible hours
$21.63 - $26.44 per hour
Description The Servicing Operations Sr Specialist will have the responsibility of supporting the receiving and delivery of mail at our... ...train within the department as needed. Ensure compliance with regulatory requirements to minimize financial risk and use expertise in...RegulatoryHourly payWork at officeLocal areaMonday to FridayFlexible hours$117k - $184.2k
...business needs into technical designs and integration workflows Ensure integration comply with organizational security standards, regulatory guidelines (e.g. GxP, HIPAA, SOX), and industry best practices. Manage data flow governance and error handling mechanisms...RegulatoryFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Scorpion Therapeutics is looking for a qualified professional to oversee quality management of submission data for worldwide regulatory applications related to drug and vaccine clinical development projects in Rahway, New Jersey. The ideal candidate will have a background...RegulatoryWorldwide
- Role Overview The Global Exhibits Advisor/Specialist partners with the Global Exhibits team to design, manage, and deliver U.S. Human Health... ...thinking and problem‑solving skills. Master of Science in Regulatory Affairs (MSRA) or related advanced certification preferred....RegulatoryWeekend workAfternoon shift
$79.2k - $124.7k
...Experience & Skills Over 2 years of hands‑on experience operating in a GMP‑compliant environment, ensuring adherence to quality and regulatory standards Proficiency in computer systems and applications including Microsoft Office (Word, Excel and Outlook) Demonstrated...RegulatoryWork at office$79.2k - $124.7k
...Experience and Skills Over 2 years of hands‑on experience operating in a GMP‑compliant environment, ensuring adherence to quality and regulatory standards Proficiency in computer systems and applications including Microsoft Office (Word, Excel, Outlook) Demonstrated...RegulatoryFor contractorsWork at officeRelocationVisa sponsorshipFlexible hoursShift work$96.2k - $151.4k
...Senior Specialist, New Product Introductions Our company is a global health care leader with a diversified portfolio of prescription... ...Procurement Management, Procurement Strategies, Production Planning, Regulatory Compliance, Risk Assessments, Risk Evaluation And Mitigation...RegulatoryContract workWork experience placementWork at officeLocal area$79.2k - $124.7k
...Experience And Skills Over 2 years of hands‑on experience operating in a GMP‑compliant environment, ensuring adherence to quality and regulatory standards Proficiency in computer systems and applications, including Microsoft Office (Word, Excel, and Outlook) Demonstrated...RegulatoryFor contractorsWork at officeRelocationVisa sponsorshipFlexible hoursShift work
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