Document Control Training Manager Jobs

Primary Responsibilities: Awareness and understanding of relevant GVP modules. Perform medical review of non-serious & serious ICSRs with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance. Experience of medical review of ICSRs received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience across multiple therapeutic areas such as Oncology, Respiratory, Immunology, Neuroscience, Rare diseases etc. Support triage of cases and determine seriousness and relatedness across products as assigned. Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling and review narrative. Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities such as implementation of quality control process. Provide medical guidance and expert opinion on the cases to the data entry associates and quality reviewers to help resolve queries. Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate. Maintain PV expertise and understanding of international safety regulations and guidelines. Responsible for completing the MR activities in the safety database within the stipulated time to comply with service level agreements and regulatory timelines. Provide timely feedback to case processors on the errors/ discrepancies noted. Assist in training/mentoring of other case processing/medical review personnel as necessitated. Adapt to different client case processing conventions and multi-task as per business needs. Perform ad-hoc tasks as advised by the team lead/manager with quality and compliance as per project requirement. Participate in organizational activities to meet objectives suitable for the role/area of expertise. Candidate Profile: Me

OVERVIEW The Data Engineer II will work closely with clients and provide technical consulting services, configuration of the elluminate platform, development for specific projects that include trial configuration, quality control, process improvements, system validation, custom analytics development, clinical software implementations and integrations. platform configuration, ETL and custom analytics development. The Data Engineer II will engage in technical development and implementation of various software service delivery related activities. As a Data Engineer II, you will play a crucial role in providing high-level technical consulting services and configuring the elluminate® platform. You will oversee specific projects, including trial configuration, quality control, and project management. KEY TASKS & RESPONSIBILITIES ➢Collaborating closely with clients to deliver technical consulting services and configure the elluminate® platform. ➢Guiding and supporting the team of data engineers on various technical service delivery activities. ➢Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate® Mapper, and Qlik. ➢Providing technical guidance, training, and support to team members and users on processes, technology, and products. ➢Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. ➢Possessing in-depth knowledge of at least one Elluminate module, with hands-on experience in all other modules. ➢Delivering proactive technical support for all client-reported support tickets. ➢Facilitating client onboarding workshops and conducting training sessions for end users on the Elluminate platform. ➢Configuring, migrating, and supporting the elluminate® platform for assigned clients. ➢Creating and maintaining all required specifications and quality control documents as per SOP and processes. CANDIDATE’S PROFI

OVERVIEW The Data Engineer II will work closely with clients and provide technical consulting services, configuration of the elluminate platform, development for specific projects that include trial configuration, quality control, process improvements, system validation, custom analytics development, clinical software implementations and integrations. platform configuration, ETL and custom analytics development. The Data Engineer II will engage in technical development and implementation of various software service delivery related activities. As a Data Engineer II, you will play a crucial role in providing high-level technical consulting services and configuring the elluminate® platform. You will oversee specific projects, including trial configuration, quality control, and project management. KEY TASKS & RESPONSIBILITIES ➢Collaborating closely with clients to deliver technical consulting services and configure the elluminate® platform. ➢Guiding and supporting the team of data engineers on various technical service delivery activities. ➢Designing, developing, testing, and deploying efficient SQL code to support SDTM, custom reports, and visualizations using tools like MS SQL, elluminate® Mapper, and Qlik. ➢Providing technical guidance, training, and support to team members and users on processes, technology, and products. ➢Managing multiple timelines and deliverables for single or multiple clients, and handling client communications as assigned. ➢Possessing in-depth knowledge of at least one Elluminate module, with hands-on experience in all other modules. ➢Delivering proactive technical support for all client-reported support tickets. ➢Facilitating client onboarding workshops and conducting training sessions for end users on the Elluminate platform. ➢Configuring, migrating, and supporting the elluminate® platform for assigned clients. ➢Creating and maintaining all required specifications and quality control documents as per SOP and processes. CANDIDATE’S PROFI

Position Summary This is a full-time, contract hybrid position in South San Francisco, CA. The Contract Design Control Scientist supports the Platform department by owning and improving design controlled documentation across the product development lifecycle. This role bridges R&D science and regulatory compliance; translating laboratory processes, study data, and software workflows into traceable, audit-ready deliverables. The ideal candidate combines a strong scientific foundation with the ability to navigate regulated environments, engage cross-functional stakeholders, and communicate complex technical concepts to audiences ranging from R&D scientists to clinical professionals. Primary Responsibilities Author and maintain design controlled documentation in compliance with FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and GDPR. Translate laboratory processes, study plans, and analytical data into traceable, compliant deliverables (e.g., development reports, verification/validation protocols, specifications). Establish and maintain traceability across project documentation, linking requirements to design outputs and verification evidence. Review development reports, team resources, and software scripts to extract and synthesize information for controlled documents. Create onboarding and training documentation for R&D and CLIA team members, including training plans and departmental practice descriptions. Manage documentation filing, version control, and change-control workflows within quality management systems. Identify opportunities to improve documentation processes, templates, and deliverable quality. Perform other duties as assigned. Qualifications BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related field) or equivalent industry experience. 5+ years of experience producing controlled documentation in the medical device, IVD, or life science industry. Demonstrated experience working in

POSITION SUMMARY The Consultant is responsible for supporting the Consulting Services Team in delivering cybersecurity, privacy, and compliance services across a diverse portfolio of client engagements. This role operates as a flexible, deployable resource, contributing to multiple concurrent or sequential engagements based on business needs. This role requires proactive initiative to study, ask questions, and rapidly learn the organization’s solutions, methodologies, and delivery standards. Consultants must be comfortable transitioning between engagements, adapting quickly to new client environments, and delivering value immediately. Consultants focus on executing client deliverables, enhancing service quality, and improving project efficiency under the guidance of senior team members. They are expected to develop broad subject matter expertise, contribute to process improvements, and build trusted relationships across a variety of clients and internal teams. SPECIFIC JOB RESPONSIBILITIES Serve as a deployable consulting resource, supporting multiple client engagements across varying industries, with a focus on healthcare. Adapt quickly to new client environments, priorities, and team structures while maintaining high-quality delivery. Support the execution of cybersecurity and compliance consulting engagements under senior leadership guidance. Work closely with clients to collect data, conduct risk assessments, gap analyses, and document findings. Assist in evaluating client security postures, including vulnerability management, compliance alignment, and risk exposure. Develop and contribute to recommendations aligned with industry frameworks such as NIST, ISO 27001, CIS Controls, and HIPAA. Support clients in designing and implementing security controls, policies, and procedures.

This position is responsible for planning, prioritization, design and implementation of enhancements to Topgolf’s Coupa Source to Pay applications and MuleSoft, PI/PO, API and SFTP interfaces between Coupa and other systems. ROLES AND RESPONSIBILITIES Own end-to-end solution design for system enhancements and new releases for Topgolf’s Coupa applications including requirements gathering, stakeholder alignment, system configuration, testing, training, SOPs and post-production support. Drive the supplier enablement efforts for key vendors, partnering with the Coupa administrator on cXML connection setup, testing, and management of cXML vendor connections. Provide support for system users on new and existing functionality as needed. Manage interfaces into and out of Coupa, including monitoring performance and errors, making corrections as needed to enable documents to properly flow in and out, determining root causes. Build and maintain forms, approval chains, analytics and AIC reports in Coupa based on the evolving needs of the business. Maintain lookup values from GL master data changes in SAP. Perform activities to support the Company’s internal control environment, including following appropriate guidelines for user access approvals, performing system change controls, and executing quarterly user reviews and control certifications. Other duties as considered necessary to support the activities of the Business Systems department, its users and the Company as a whole. TECHNICAL COMPETENCIES (Knowledge, Skills & Abilities) Excellent attention to detail and organization skills to prioritize deadlines and keep up with open tasks, as demonstrated by prior project objectives being successfully delivered. Strong analytical and problem solving skills to break down complex problems into achievable solutions. Ability to be a self sta

Our vision is to transform how the world uses information to enrich life for all . Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. Job Description: 1.Primarily focused on the prevention of accidents, incidents, and events that harm people, property. 2.Responsible for safety and health management; to comply and support safety and healthy activities of legal requirement and company requirements, guidelines and standard. Responsibilities and Tasks: 1.To develop the EHS standard by Micron Policy and legal requirement. 2.Ensure all the operation onsite in accordance with legal requirement. 3.Leading and participating in ISO45001, TOSHMS operation. 4.Conducting accident and incident investigations and identify controls to prevent their reoccurrence. 5.Developing, suggesting and conducting health and safety training. 6.Conducting construction safety management. 7.Conducting dangerous workplace management and process safety assessment. 8.Conducting management of change. 9.Conducting Risk management. 10.Conducting contractor management. 11.Conducting high-risk work management. 12.Conducting semiconductor equipment safety management. 13.Developing and conducting lockout-tagout system. 14.Responsible for government document application. 15.To cooperate with EHS activities. Education/Experience/Qualifications: 1.College or university degree and Industrial Safety/ Health engineering related. 2.Have Safety/ Health engineering related work experience more than 1-3 years. 3.Occupational Safety / Health Specialist or Occupa

Instawork is on a mission to create meaningful economic opportunities for skilled hourly professionals in communities around the globe. Our AI-powered labor marketplace helps local businesses scale, and enables global technology companies to push the frontiers of robotics and AI. Backed by world-class investors like Benchmark, Spark Capital, Craft Ventures, Greylock, Y Combinator, and others, we’re looking for exceptional talent to reimagine the way the world works. Position Summary We seek a QA Specialist to validate robotic training videos using our automated quality assessment platform. You’ll use existing tools to ensure high-quality training data for robotic manipulation systems. Key Responsibilities Daily Operations Run automated QA platform to grade robotic training videos (A/B/C/D/F scoring) Review quality reports with visibility and motion assessment results Apply Green/Yellow/Red classification based on automated platform outputs Flag videos requiring manual review when confidence scores are low Quality Control Monitor training data quality using established metrics and thresholds Identify common quality issues in robotic clamp operation videos Document quality patterns and maintain consistent standards Generate daily/weekly quality reports for robotics teams Performance Expectations Process 50+ videos daily using the automated platform Maintain 95% accuracy in quality validation decisions Complete quality reports within established timelines Follow standard procedures for quality assessment workflows Required Qualifications Essential Experience Experience with automated tools for quality validation Understanding of video/image quality concepts Background in data validation or quality control processes Core Skills Strong attention to detail for quality assessment Analytical thinking to interpret quality metrics Basic technical aptitude for using QA software platforms Communication skills for reporting and documentation Our Values Empath

About Clutch We’re on a mission to reinvent how people buy, sell, and own cars. Are you game? Clutch is Canada’s largest online used car retailer, delivering a seamless, hassle-free car-buying experience to drivers everywhere. Customers can browse hundreds of cars from the comfort of their home, get the right one delivered to their door, and enjoy peace of mind with our 10-Day Money-Back Guarantee… and that’s just the beginning. Named four years in a row to The Globe & Mail’s list of Canada’s Top Growing Companies, and awarded spots on Deloitte’s Technology Fast 50™ and Fast 500™, we’re looking to add curious, hard-working, and driven individuals to our growing team. Headquartered in Toronto, Clutch was founded in 2017 and currently services Ontario, New Brunswick, Nova Scotia, and Prince Edward Island. Our world-class investors include Altos Ventures, Canaan, FJ Labs, BrandProject, and Upper90. To learn more, visit clutch.ca. About the Role We are seeking an Entry-Level Vehicle Inspector to join our Mississauga production facility. In this role, you will ensure every vehicle meets Clutch’s high standards for cosmetic and functional quality before delivery or further production. You’ll work with our production and quality assurance teams to inspect vehicles, document findings, and support continuous improvement in our processes. What You’ll Do Perform detailed inspections of vehicles to ensure they meet company standards. Evaluate exterior and interior condition, including paint, trim, and upholstery. Test vehicle functionality, including windows, mirrors, HVAC systems, and advanced safety or connectivity features. Record inspection results using iPads and specialized inspection software. Collaborate with production, repair, and quality assurance teams to resolve issues. Ensure all work is completed safely and in compliance with company policies. What We’re Looking For High school diploma or equivalent; training in automotive inspection or quality control is a p

CPI Security is hiring a Product Specialist – Security, Video, Fire and Access Control Solutions , based at our office in Charlotte, North Carolina , to support the evaluation, testing, documentation, and rollout of intrusion, video, fire, and access control solutions for CPI’s residential and commercial product portfolio. CPI Security was founded in 1991 on an entrepreneurial spirit and a passion for helping and protecting others. What started as a company of 10 employees and 300 customers has grown into one of the nation’s top 10 largest security providers with over 750 employees. CPI has received many awards for excellence, including SDM Dealer of the Year, Central Station of the Year, and the Marvel Award. What You’ll Do: In this role, you will work with the Product Team, Operations, manufacturers, and service providers to test, validate, and support security products and related technologies. This position is hands-on and operational, focused on ensuring CPI delivers reliable, high-quality solutions for both residential and commercial customers. You will assist with product testing, beta programs, field feedback, documentation, training support, and issue resolution for intrusion, video, fire, and access control solutions, including connected technologies such as IP networking, cloud-based platforms, SaaS tools, IoT devices, video analytics, and cybersecurity-related product requirements. Essential Functions Test and evaluate new and existing intrusion, video, fire, and access control products, features, hardware, software, and integrations. Support beta programs, product pilots, and field trials with internal teams, manufacturers, and service providers. Document product performance, installation requirements, troubleshooting steps, known issues, and recommended best practices. Assist with technical documentation, solution diagrams, training materials, SOPs, and support resources. Work with Operations, QA, Technical Support, Sales, and customers to troubl

Job Title: Aseptic Pharmacy Technician Banding: 5 Location: Bradford Start Date: ASAP End date: April Hourly Rate: £19-£21 Working Hours: 37.5 Job Overview We are seeking an experienced Aseptic Pharmacy Technician to join our team. The successful candidate will be responsible for the accurate preparation, assembly, and documentation of sterile medicinal products within an aseptic environment. This role ensures compliance with regulatory standards, aseptic technique, and quality assurance procedures to support safe and effective patient care. Key Responsibilities Prepare sterile pharmaceutical products, including intravenous admixtures, cytotoxic drugs, parenteral nutrition, and other aseptic preparations, in accordance with approved procedures. Operate within controlled cleanroom environments, maintaining strict aseptic technique and contamination control. Follow Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), and relevant regulatory guidelines. Accurately label, check, and document all aseptic preparations. Perform routine cleaning, environmental monitoring, and equipment checks within aseptic areas. Participate in validation, media fills, and competency assessments as required. Assist in stock control, storage, and rotation of raw materials and consumables used in aseptic services. Identify, report, and document deviations, incidents, and near-misses in line with quality systems. Work collaboratively with pharmacists, technicians, and other healthcare professionals to meet service demands. Support training of new staff and contribute to continuous quality improvement initiatives. Qualifications and Experience Accredited Pharmacy Technician qualification (or equivalent). Registration with the relevant professional or regulatory body (where applicable). Previous experience working in an aseptic or cleanroom environment is highly desirable. Knowledge of aseptic techniques, GMP, and infection control principles. Why Choose Pulse? Competitive p

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA. For more information, visit our website at www.kincellis.com. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Utilize proficiency in Microsoft Word, Excel, PowerPoint, and other relevant applications to support manufacturing operations. Apply knowledge of aseptic processing, cell culture, and cell therapy manufacturing within a cGMP-regulated environment. Maintain strict adherence to personal protective equipment (PPE) requirements to ensure a safe and compliant workspace. Collaborate with cross-functional teams to draft, revise, and maintain Standard Operating Procedures (SOPs). Perform Quality Control (QC) evaluations as part of in-process and final product assessments within the manufacturing environment. Demonstrate an understanding of material flow and proper disinfection procedures for transferring materials into cleanroom areas. Take personal responsibility for maintaining a safe work environment and completing all assigned training requirements on time. Partner with the Investigation team to support root cause analysis and

Our vision is to transform how the world uses information to enrich life for all . Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring the world to learn, communicate and advance faster than ever. Attn: This is for interns who have completed this summer internship and are expected to be converted. Please do not apply unless you were instructed to apply to this posting. We are seeking motivated and technically curious recent community college graduates to join our team as Technicians for various areas. This is an entry‑level, hands‑on role designed to launch your career in advanced manufacturing. You will support the installation, operation, troubleshooting, and maintenance of complex manufacturing equipment while working alongside experienced technicians and engineers. Responsibilities: Perform preventive and corrective maintenance on manufacturing equipment Troubleshoot mechanical, electrical, pneumatic, and basic control system issues Assist with equipment startups, qualifications, and process improvements Read and interpret schematics, manuals, and standard operating procedures Accurately document work performed and equipment status in maintenance systems Follow all safety, quality, and cleanroom/manufacturing protocols Collaborate with engineering, production, and facilities teams Participate in structured onboarding, technical training, and mentorship Leveraging AI Minimum Qualifications: Associate degree or recently completed certificate from a community or technical college in a relevant field such as: Mechatronics <

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Sr. Regulatory Affairs Associate – CONSULTANT for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role J ob Title: Sr. Regulatory Affairs Associate – CONSULTANT Responsibilities: Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. The high-level activities may include but are not limited to: Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations Draft, create or update TDs in collaboration with Platform RA SME. Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders. Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s) Work with the cross functional teams and Company’s

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Sr. Regulatory Affairs Associate – CONSULTANT for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. About the Role J ob Title: Sr. Regulatory Affairs Associate – CONSULTANT Responsibilities: Regulatory Affairs Associate will actively collaborate with the Company’s regulatory project team to review, update, and create Technical Documents (TDs) in accordance with EU MDR and other applicable regulatory requirements. The high-level activities may include but are not limited to: Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations Draft, create or update TDs in collaboration with Platform RA SME. Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders. Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., Verify TD documents are approved and contain the most recent revision(s) Work with the cross functional teams and Company’s local