Job Summary: 

• Provide clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (Lab DM) for the studies awarded to IQVIA Biotech, and meet the internal/external client data reporting needs.
• Serve as the primary point of contact for lab data management deliverables
• Manage project timelines and quality issues, and identify and justify out-of-scope
• Unit Testing of Lab Module
• Enter data in the Development or QC systems that will be used for validation.
• Provide feedback to the Lead DM and Programmers to improve the deliverables.
• Lab Administration Module revisions based on project needs (i.e., add Analyte Names, Units, Unit Dictionaries, etc.)
• Creation of the Lab ID Worksheet/Protocol Specific Normal Ranges Spreadsheet based on CRF-specific lab forms.
• Provide Lab Metrics for Project Management for Billing
• Provide feedback to improve the data management system or reports
• Discuss roadblocks for getting processes done promptly
• Produce Study Metric reports to the internal/external project team
• Provide the DM lead or PM with status updates on tasks

Skills on Resume: 

• Clinical Data Expertise (Hard Skills)
• Lab DM Coordination (Hard Skills)
• Timeline Management (Soft Skills)
• Quality Oversight (Hard Skills)
• Unit Testing (Hard Skills)
• System Data Entry (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Process Improvement (Soft Skills)

Job Summary: 

• Understand all R&D activities and requirements, establish lab management strategies with R&D Managers/Scientists, and write and document lab management policies.
• Understand EHS requirements, document internal EHS rules, and implement the regulations in daily R&D activities.
• Understand the quality standard ISO13485, write and document lab management procedures to meet the quality system requirements.
• Train R&D members and ensure their activities follow all internal procedures and policies.
• Monitor inventory and order supplies, e.g., chemicals, reagents, consumables, instruments, and personal protective equipment.
• Manage and maintain lab facilities and instruments, ensure they function correctly, and initiate repair or maintenance
• Manage lab supplies in an organized manner to ensure efficient R&D activities, including reagents, general chemicals, hazardous chemicals, biological materials, and consumables.
• Maintain a clean and organized lab environment.
• Implement regular cleaning, monitor the lab environment daily.
• Organize, archive, and manage all lab-related documents, e.g., product IFUs, certification, calibration reports, etc.
• Support IT on lab system access management, and support R&D scientists on data management.
• Support QA on lab-related QMS documents and internal/external audits.

Skills on Resume: 

• Lab Management (Hard Skills)
• EHS Compliance (Hard Skills)
• Quality Documentation (Hard Skills)
• Staff Training (Soft Skills)
• Inventory Control (Hard Skills)
• Facility Maintenance (Hard Skills)
• Document Management (Hard Skills)
• Audit Support (Hard Skills)

Job Summary: 

• Perform performance tests according to the project/activities plan and provide official test reports.
• Identify key operation activities for every project in terms of test plan, execution, and timing.
• Develop and update the internal testing manual based on technological evolutions and market needs.
• Define specifications for components and parts in prototype creation and testing execution.
• Implement optimization and statistical analysis tools during the testing phase.
• Interact with all R&D functions to ensure a seamless delivery of projects.
• Minimize trial and error activities and costs, and improve the “right first time” RFT result in the testing outcomes.
• Plan and organize work for at least 1 week, identifying priorities and agreeing, and reviewing work plans with the project leader
• Follow up on new developments and innovations from suppliers and assess potential opportunities

Skills on Resume: 

• Performance Testing (Hard Skills)
• Test Planning (Hard Skills)
• Manual Development (Hard Skills)
• Specification Definition (Hard Skills)
• Statistical Analysis (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Cost Optimization (Hard Skills)
• Work Prioritization (Soft Skills)

Job Summary: 

• Ensures compliance with cGMPs, Environmental, Health, and Safety regulations.
• Executes all Quality Control activities to ensure the timely and compliant launch of finished products.
• Executes all routine Quality Control testing to ensure timely and compliant release of finished products.
• Executes the finished product Exception Program.
• Supports regulatory requirements of finished products
• Supports the timely receipt and release of finished products.
• Prepares and executes method development, validation plans, and protocols for the laboratory.
• Supports the document control system and record retention.
• Ensures laboratory equipment is calibrated and properly maintained at all times
• Executes and supports batch record reviews to ensure the timely release of finished product according to schedule.
• Develops and implements Standard Operating Procedures.
• Promotes the maintenance of a safe, accident-free free and healthy work environment.

Skills on Resume: 

• Regulatory Compliance (Hard Skills)
• Quality Control (Hard Skills)
• Routine Testing (Hard Skills)
• Exception Handling (Hard Skills)
• Regulatory Support (Hard Skills)
• Product Release (Hard Skills)
• Method Validation (Hard Skills)
• Document Control (Hard Skills)

Job Summary: 

• Review laboratory data and audit to ensure accuracy. 
• Maintain QA records (i.e, logbooks, equipment records, specifications, procedures).
• Review procedures, SOPs, instrument IQ/OQ protocols and reports, method validation and implementation protocols and reports, and other documentation for regulatory compliance.
• Coordinate responses to internal, customer, and regulatory inspection observations.
• Coordinate and perform internal audits.
• Monitor inspection trends for impact on laboratory operations.
• Ensure the proper storage of controlled documentation, like archives and back-ups.
• Maintain documentation, certifications, and training records
• Establish, institute, and provide new employee orientation for QA related activities.

Skills on Resume: 

• Data Auditing (Hard Skills)
• Record Management (Hard Skills)
• Compliance Review (Hard Skills)
• Inspection Coordination (Soft Skills)
• Internal Auditing (Hard Skills)
• Trend Monitoring (Hard Skills)
• Document Control (Hard Skills)
• Employee Training (Soft Skills)

Job Summary: 

• Perform repair, troubleshooting, maintenance, and calibration of high complexity instrumentation for Color’s labs
• Coordinate with users on expected downtime and the status of instrumentation.
• Understand and investigate the root cause of instrumentation issues by working closely with users, automation development teams.
• Suggest and implement solutions and improvements
• Act as a key subject matter expert on instrumentation support.
• Coordinate, prepare, oversee, and perform installation of new instrumentation, relocations, repairs, or moves primarily for high complexity instrumentation.
• Work closely with the Lab Ops team to prepare and scope out space and power requirements
• Ensure proper documentation of IQ, OQ, and PQs is complete per SOP to prepare instrumentation for use in production.
• Participate in writing SOPs and defining requirements for new instrumentation validation, maintenance, and calibration schedules.
• Create and maintain a PM and calibration schedule for instrumentation and coordinate instrument downtime with the laboratory.
• Act as subject matter expert for instrumentation associates and support them in troubleshooting efforts for all other instrumentation.
• Learn to be a superuser for Color’s ticketing system
• Enter and edit work orders, build and maintain dashboards, update and improve workflows, and generate reports.
• Present reports at laboratory management meetings.
• Work with the instrumentation team as well as external vendors to ensure issues are resolved quickly and all follow-up documentation is complete.
• Participate in rotational on-call duty during off-hours to respond to instrumentation problems.

Skills on Resume: 

• Instrumentation Repair (Hard Skills)
• Issue Troubleshooting (Hard Skills)
• Root Analysis (Hard Skills)
• Solution Design (Hard Skills)
• Instrument Installation (Hard Skills)
• SOP Writing (Hard Skills)
• Workflow Coordination (Soft Skills)
• Team Communication (Soft Skills)

Job Summary: 

• Work with engineers and specialists to learn the science behind the cell culture operations of the manufacturing process
• Be responsible for writing protocols, executing studies (small-scale and large-scale), and writing reports to support process characterization and validation activities per the Validation Project Plan and Tech Transfer Activities
• Assist in laboratory operations, including media and bioreactor preparation, maintaining analytical equipment, and monitoring of cell culture step performance
• Complete small-scale experiments for scaling down bioreactor operations
• Be responsible for coordinating technical meetings (ie, setting up the meetings, communicating the agenda, and drafting minutes)
• Assist in review of User Requirement Specifications, Critical Assessments, System Impact Assessments, and Risk Assessments
• Project debug and implementation support
• Plan, carry out, and analyze laboratory experiments following discussion with the project leader
• Develop color and colorant formulations according to formulation guidelines
• Interpret results and make proposals for continuation of work, write reports and short presentations, and communicate with R&D teams in Paints and Coatings

Skills on Resume: 

• Cell Culture (Hard Skills)
• Protocol Writing (Hard Skills)
• Study Execution (Hard Skills)
• Lab Operations (Hard Skills)
• Meeting Coordination (Soft Skills)
• Risk Assessment (Hard Skills)
• Project Debugging (Hard Skills)
• Data Interpretation (Hard Skills)

Job Summary: 

• Conduct routine laboratory tests, including the necessary checks and operations of equipment required in the laboratory.
• Work and review for accuracy and overall adequacy.
• Provide records of such equipment and others to the customer representative at the customer site.
• Carry out all required actions safely in the standard operations manual.
• Perform other related duties and handle special projects
• Conduct all business activities in accordance with Baker Hughes HSE policies, legal compliance requirements, and Baker Hughes Core Values.
• Maintain lab equipment and test stations (mechanical, electrical, tooling)
• Ownership of lab safety (PPE, cell risk assessments, chemical intake forms, etc.)
• Optimize lab orientation/workflow as engineering priorities change
• Ensure labs are organized and kept at 5S standards (six sigma)
• Recommend improvements to the lab in terms of equipment and configuration.

Skills on Resume: 

• Laboratory Testing (Hard Skills)
• Accuracy Review (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Safety Compliance (Hard Skills)
• Lab Organization (Hard Skills)
• Workflow Optimization (Hard Skills)
• Safety Ownership (Soft Skills)
• Process Improvement (Soft Skills)