Responsibilities Preparation of project files as needed, which may include:
File conversion and formatting from one file format to another (ex. from PDF to Word),
Recreation of dead text in source documents,
Other source formatting adjustments as requested by clients to prepare the files for CAT tool import,
File alignments in the CAT tool
Other quality control tasks, as needed
Review and correct the layout of translated documents that are exported from the CAT tool.
Troubleshoot document formatting issues as needed. Coordinate and communicate with project managers in a professional and timely manner.
Provide input and suggestions towards innovating new approaches and product features tailored to team formatting needs.
Ensure client satisfaction with formatting on all projects under his/her responsibility
Education
Associates Degree in appropriate field of study, preferably in graphic design or similar field,
2+ years of word processing/desktop publishing experience preferred,
Or any equivalent combination of experience and/or education from which comparable knowledge, skills and abilities have been achieved
Required Experience/Skills
Expert knowledge of Microsoft office (Word, Excel, PowerPoint)
Advanced knowledge of InDesign
Experience with formatting and layout requirements of various languages, including Right-to-Left languages or character-based languages
Excellent interpersonal, organizational, time management, and communication skills
Preferred Experience/Skills
Experience with CAT tools and OCR software
Experience with Illustrator and Photoshop
Familiarity with the translation industry
Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Apply here: **********************
$38k-52k yearly est. 60d+ ago
Looking for a job?
Let Zippia find it for you.
Human Resources Generalist
Integrated Resources 4.5
Raleigh, NC job
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
JOB SUMMARY
Should have experience in recruitment 50% and 50% in HR operation and Employee relations.
Responsible for supporting the NC R&D group, to include recruiting, new hire onboarding, employee relations, workers compensation, benefits administration, performance management, exit interviews. This role will also assist with company announcements/communications, immigrations issues, legal issues, maintain personnel and other HR-related files, administer LOA, and relocation. Some administrative duties.
REPORTING RELATIONSHIPS
Reports to the President, R&D, USA and may have 0-1 direct reports
REQUIRED
Bachelor's degree in HR, or related field with experience of min. 3+ years Must have very strong knowledge all employment laws from ACA, FMLA, NJFLA, ADA, ADEA, COBRA, USERRA, OSHA, PDA, IRCA, HIPAA, DOL
unemployment claims, FLSA, Title VII - wage and hour laws, EEO-1 Annual report, etc…. Excellent Knowledge of MS Word, Excel, & Outlook (this should include - tables in Word, as well as macros, pivot tables, V-lookups in Excel) Excellent communication skills, both oral and written Attention to detail Ability to multitask and work on their own with little or no supervision most of the time; this includes excellent listening and decision making. Approachable with exceptional customer service Should be willing to work more than 8 hours a day if needed
Additional Information
Thanks & Regards,
Sweta Verma
Integrated Resources Inc | Team Recruitment | 732-549-5907
$53k-79k yearly est. 3d ago
Windows System Administrator
Integrated Resources 4.5
Raleigh, NC job
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
JOB SUMMARY:
This Windows Systems Administrator position requires a highly motivated individual with the ability to work independently, in a dynamic environment. The Windows Systems Administrator will be directly responsible for participating in the design and support of all managed Windows operating system infrastructure activities in a 24x7x365 multi-site data center environment. This position requires the ability to excel at multi-tasking and have the experience to ramp up quickly in a dynamic, high-tech environment.
ESSENTIAL FUNCTIONS:
• Setup, configure, and perform day-to-day maintenance and administration of Windows systems
• Provide Active Directory and Group policy management and support
• Manage domain, user/computer objects, accounts, and permissions
• Perform day-to-day break-fix, troubleshooting Windows related issues, performance issues, etc.
• Assist with configuring fibre channel multipathing on VMware and Windows hosts
• Maintain Windows best practices, anti-virus, and patch management including firmware upgrades
• Provide Windows monitoring and reporting solutions
• Maintain partnerships and leveraging market technologies associated with vendors and product enhancements
• Ability to learn new systems and applications as necessary
• Ensures software licenses are current and compliance with licensing laws are observed
• Evaluate new technologies and recommend future direction of Windows infrastructure.
• Support corporate system audits by maintaining accurate, comprehensive documentation and providing timely responses to requests
• Provide written documentation for team processes and service continuity plans (Disaster Recovery).
• Support Change Management process by adhering to guidelines and providing proper documentation
• Comply at all times with the Standards, policies and Code of Business Conduct and Ethics
REQUIREMENT:
This position is responsible for the configuration, installation, deployment, maintenance, and monitoring of all Windows operating system servers. This position also provides technical and operational support to server end-users. Coordinates with internal staff and external vendors to provide maintenance and repairs to the Windows OS infrastructure to ensure smooth delivery of services to all users. Performs all other duties as assigned and implements and performs according to the established standards.
Required Skills:
• 5+ years of Production Windows Operating System Support experience
• 5+ years' experience with VMware 5/5 / 6 and SAN technologies
• 5+ years' experience with Windows clustering, Microsoft SQL, and Microsoft IIS
• 2+ years' experience with cloud-based Windows environments
• Thorough understanding and experience with WSUS
• Understanding of DNS/TCP/IP and LAN/WAN connectivity
• Experience with system security requirements and server hardening practices
• Experience with Disaster Recovery preparedness and recovery services
• Ability to establish and maintain Windows architecture best practices and standards, including procedures, templates, and relevant documentation
• Familiarity with replication software such as Vreplicator
• Ability to author, edit, and debug PowerShell scripts
• Familiarity with HP hardware, including blade chassis
• Outstanding verbal and written communication skills
• Vendor Management and Negotiation
• Microsoft Office Suite
Preferred Skills:
• PowerShell experience
• Microsoft Azure experience
• Microsoft Office 365 experience
• SOX/PCI compliancy standards
• GxP Experience
• Experience with Linux in an enterprise environment a plus
Core Competencies:
• Outstanding Verbal and Written Communication Skills
• Analytical and Problem Solving Skills
• Initiative
• Ownership
• Decision Making
• Multi-tasking
• Interpersonal Effectiveness
• Customer Focused
• Flexibility
• Self-Management
• Collaboration
Qualifications
Qualifications:
• Bachelor's degree from a four-year college or university, preferably in IT or a related field.
• Minimum of 5+ years of related experience and/or training or equivalent combination of education and experience.
Additional Information
Ankita Teja
Technical Recruiter
Integrated Resources Inc.
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Tel: 732-429-1919
Fax: 732-549-5549
A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
REPORTING RELATIONSHIPS
Will report to President, R&D, USA. May be responsible for managing up to 2 RA staff including U.S. and India.
DUTIES & ESSENTIAL JOB FUNCTIONS
This position is responsible for all Regulatory Strategy and Filing aspects of MDI aerosols development, including CMC and possibly, Clinical strategy.
OTHER FUNCTIONS AND RESPONSIBILITIES
Keep abreast of new Regulatory and Scientific developments in the Respiratory area.
Additionally take on Derma & Transdermal RA responsibilities.
QUALIFICATIONS
Regulatory experience
supporting Generic Respiratory MDI aerosols development is a must!
Good scientific/technical understanding of the MDI aerosols space
Excellent written and spoken communication skills
Excellent interpersonal skills
Attention to details, quality and follow-through
Project management and excellent time-management and organization skills
Excellent analytical skills and problem solving ability
DUTIES & ESSENTIAL JOB FUNCTIONS
40% - Develop and provide Strategic Regulatory guidance/advice to Project Teams
30% - Manage all Regulatory aspects of Respiratory ANDA filings
20% - FDA interactions via e-mail, tel., mtgs, conferences
5% - Provide updates to senior & executive management
5% - Recruiting, training, team building
Qualifications
JOB DESCRIPTION
Education:
Master's/PhD - in Chemistry/Pharm. Sciences
Experience:
Must have MDI generics filing experience (not Nasal or other dosage forms); interacting with the FDA, developing Regulatory strategy
8 + years total, and in MDI aerosol generics - 5+ years
Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
Additional Information
Thanks
Warm regards
Avleen Kaur
732-318-6945
$101k-145k yearly est. 3d ago
Manufacturing Technician
Integrated Resources 4.5
Sanford, NC job
IRI believes in commitment, integrity and strategic workforce solutions.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Location: Sanford, NC
Duration: 12 Months +
Our Client is looking for Manufacturing Technician
Job Description:
• The person filling this position operates all equipment in two assigned Manufacturing areas.
• He or she will also clean equipment and facilities, and provide documentation of all duties in accordance with Good Manufacturing Practices. Incumbent will perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures.
• The incumbent will be required to attend quality-training programs and orientations on an annual or as needed basis.
• This individual will be required to become familiar with domestic and international regulatory requirements associated with manufacturing and biological processes.
• Annual performance goals and objectives will be evaluated against specific quality performance requirements as defined by the Manufacturing Supervisor.
• Mandatory commitment to report to management any potential or actual deviations from regulatory requirements.
• Master documentation procedures by following detailed written and verbal instructions in order to complete assigned tasks (follow area SOP's).
• Demonstrate knowledge of procedures by performing tasks and duties and maintaining detailed records in a manner compliant with cGMPs.
• Perform routine job duties, which may include vacuuming, mopping ceilings, walls and floors, emptying trashcans, etc.
• Prepare production glassware and other equipment by operating industrial washers, autoclaves and dehydrogenation ovens.
• Clean and sterilize process equipment (tanks, fermenters) as needed.
• Demonstrate and instruct proper gowning and aseptic processing procedures.
• Operate and troubleshoot production equipment in assigned area and report unusual conditions or concerns about the process or equipment to area Supervisor.
• Train new employees on production processes.
• Perform lab work, such as: performing sample dilutions, pH, and conductivity readings.
Qualifications
The following combinations of education and work experience are considered acceptable:
BA/BS Tech/Bus/Industry/Science with minimum 2 years direct regulated manufacturing pharma/biotech experience
• AAS Science related with minimum 4 years direct regulated manufacturing pharma/biotech experience
• HS or equivalent with minimum 8 years direct regulated manufacturing pharma/biotech experience
• Or progression from Bio-processing Technician Level I that includes additional internal development curriculum List certificates (if any) required.
1. Must complete training in assigned area and comply with applicable safety, OSHA, and environmental safety requirements.
2. Must complete training and comply with applicable cGMP requirements.
State type and minimum number of years of prior experience required to perform job duties.
Additional Information
Regards
Savita Khashu
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE | GSA - Schedule 66 I GSA - Schedule 621 I
Tel: 732 429 1645
(W) 732-549-2030 x 223
(F) 732-549-5549
|www.irionline.com
$33k-43k yearly est. 60d+ ago
Utilization Review Nurse (RN)
Integrated Resources 4.5
Raleigh, NC job
A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
· The incumbent must possess medical management/clinical decision-making skills and sound skills in assessing, planning and managing member care.
· Advanced assessment and teaching skills.
· Problem solving skills.
· Familiarity with legal terminology and liability issues and ability to handle ethical or risk management issues.
· Utilization and Quality Management/Outcomes experience preferred.
· Previous work experience with a managed care organization or provider is also preferred.
· Prior experience in case management, home health, discharge planning, or Concurrent review.
Qualifications
· RN Diploma, RN Associate's degree or Bachelors of Science in Nursing (BSN) degree.
· Minimum of 3 years clinical experience in an acute medical or acute surgical setting.
· Proficiency with a Microsoft Windows operating system.
· Must have valid license to practice nursing within the US and have started application for NC nursing license.
Additional Information
With Regards,
Kavita Kumari
Allied Healthcare Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Tel: 732-549-2030 x208
Fax: 732-549-5549
Direct: 732-549-5302
$58k-74k yearly est. 3d ago
Technical Data Entry Clerk
Integrated Resources 4.5
Durham, NC job
IRI believes in commitment, Integrity and strategic workforce solutions.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Job Description
Hi ,
I came across your resume. I have an immediate opportunity with our direct client. Following is the position details. Please let me know if you are available/interested so we can further discuss this position. Also email me your resume and contact number where I can call
Technical Data Entry Clerk
Location: Durham (RTP), NC
Duration: 6+ Months
Qualifications:
• Bachelor's degree in Computer Science or related discipline or equivalent experience.
• At least 2 years of experience with data collection and entry in GxP environments.
• Experience supporting internal customers with requests for data and/or documents from archive.
• Experience with software/database design and testing. The ideal candidate must possess a college degree and have excellent computer skills.
• Must be proficient with MS Office applications, including Word, Access, Excel, and SharePoint. Familiarity with SQL*Server is a plus.
• Must be team oriented and have strong interpersonal skills and attention to details.
• Must have excellent communication, organization and time management skills.
• Must be responsible and extremely reliable.
• Must be knowledgeable of 21 CFR Part 11 requirements and validation.
Responsibilities:
This position will work as part of a team to coordinate and organize biocompatibility testing data and related documentation performed on products in the Client portfolio. This position will be responsible for the creation, updating, and maintenance of data in a computerized system as well as archiving activities. This role will also provide assistance with the design and implementation of the data repository.
1. Entry, update, and maintenance of data into a computerized system.
2. Assist with design and implementation of a data repository.
3. Archive data as applicable (electronic and/or hard copy).
4. Performs other duties as assigned.
Feel free to forward the job to your friends or colleagues who might be available or interested for this position!!
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732 - 318 -6506 | (W) # 732-549-2030 - Ext - 324 | (F) 732-549-5549
Email id - seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
edison NJ
Qualifications
Hi ,
I came across your resume. I have an immediate opportunity with our direct client. Following is the position details. Please let me know if you are available/interested so we can further discuss this position. Also email me your resume and contact number where I can call
Technical Data Entry Clerk
Location: Durham (RTP), NC
Duration: 6+ Months
Qualifications:
• Bachelor's degree in Computer Science or related discipline or equivalent experience.
• At least 2 years of experience with data collection and entry in GxP environments.
• Experience supporting internal customers with requests for data and/or documents from archive.
• Experience with software/database design and testing. The ideal candidate must possess a college degree and have excellent computer skills.
• Must be proficient with MS Office applications, including Word, Access, Excel, and SharePoint. Familiarity with SQL*Server is a plus.
• Must be team oriented and have strong interpersonal skills and attention to details.
• Must have excellent communication, organization and time management skills.
• Must be responsible and extremely reliable.
• Must be knowledgeable of 21 CFR Part 11 requirements and validation.
Responsibilities:
This position will work as part of a team to coordinate and organize biocompatibility testing data and related documentation performed on products in the Client portfolio. This position will be responsible for the creation, updating, and maintenance of data in a computerized system as well as archiving activities. This role will also provide assistance with the design and implementation of the data repository.
1. Entry, update, and maintenance of data into a computerized system.
2. Assist with design and implementation of a data repository.
3. Archive data as applicable (electronic and/or hard copy).
4. Performs other duties as assigned.
Feel free to forward the job to your friends or colleagues who might be available or interested for this position!!
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732 - 318 -6506 | (W) # 732-549-2030 - Ext - 324 | (F) 732-549-5549
Email id - seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
edison NJ
$24k-31k yearly est. 60d+ ago
Bench Scientist
Integrated Resources 4.5
Sanford, NC job
IRI believes in commitment, integrity and strategic workforce solutions.
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Job Description
The incumbent will assist the Manufacturing Science and Technology (MSAT) organization supporting biological therapeutics. The incumbent responsibilities will include the following:
• Support lab or pilot-scale experiments involving conjugation of antigens to a carrier protein
• Execution of lab or pilot-scale purifications using Tangential Flow Filtration (TFF), Normal Flow Filtration (NFF), and/or column chromatography, as needed
• Preparation of equipment, solutions, consumable materials, etc. as needed to support experiment execution
• Preparation of technical reports and presentations to communicate results to scientists and management, as required.
Qualifications
• Bachelor's degree or graduate degree in Chemistry, Chemical Engineering or related biotechnology field
• Industrial experience is preferred
• Experience with operating and monitoring of Tangential Flow Filtration (TFF), Normal Flow Filtration (NFF), and chromatography systems is desired
• Experience with conjugation chemistry is highly desired
Additional Information
Warm Regards
Ricky Bansal
732-429-1925
$71k-107k yearly est. 60d+ ago
Data Entry Coordinator
Integrated Resources 4.5
Durham, NC job
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Job title: Data Entry Coordinator
Job location: Research Triangle Park NC
Duration: 12+ months (possibilities of extension)
ROLES
Data Entry Specialist
needed to perform data entry duties associated with pharmaceutical and biological GMP data.
This position will receive data from multiple sources, organize the data received, enter the data into a validated database, and archive the data received.
Training on the database systems will be provided.
Attention to detail and a strong work ethic are required.
Experience is helpful but not required.
RESPONSIBILITIES:
Data entry of data from multiple sources into a validated database in a timely manner
Archival of original data from multiple sources in a documentation system
Maintain Excel spreadsheets, as needed
REQUIREMENTS:
Decision making skills to effectively manage moderate volume email
Solid work ethic with the ability to handle multiple tasks/priorities
Proficiency in Excel and Word
Flexible self-starter and results-oriented
Minimum average level of typing ability
Additional Information
We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.
Thanks & Regards,
Seema Chawhan
Clinical Recruiter
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE
|
GSA - Schedule 66
I
GSA - Schedule 621I
DIRECT # -
732-844-8724
|
LinkedIn:
https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™
for Health Care Staffing
“INC
5
0
0
0
's
FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$65k-93k yearly est. 3d ago
Director, Patient Recruitment
Icon Plc 4.8
Icon Plc job in Raleigh, NC
Director, Patient Recruitment - Remote - US ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Director, Patient Recruitment to join our diverse and dynamic team. As a Director, Patient Recruitment at ICON, you will be responsible for delivering a centralized patient recruitment strategy, acting as point of contact and collaborative partner between internal and external stakeholders
What you will be doing
* Developing and implementing patient recruitment strategies for clinical trials, utilizing a variety of channels and tactics to identify and enroll suitable participants.
* Collaborating with study teams to forecast patient recruitment timelines and develop recruitment plans aligned with study objectives and timelines.
* Overseeing the execution of patient recruitment activities, including advertising campaigns, outreach initiatives, and patient engagement programs.
* Monitoring and analyzing recruitment metrics to evaluate the effectiveness of recruitment efforts and identify opportunities for optimization.
* Providing guidance and support to study teams and external partners on patient recruitment best practices and regulatory requirements.
Your profile
* Bachelor's degree in life sciences, marketing, or a related field; advanced degree preferred.
* Minimum of 7 years of experience in patient recruitment for clinical trials, with at least 3 years in a leadership role.
* Deep understanding of the clinical trial process and regulatory landscape, with knowledge of patient recruitment strategies and tactics.
* Proven track record of successfully designing and implementing patient recruitment plans for complex clinical trials across various therapeutic areas.
* Demonstrated history untilizing multple channels for recruitment, including EHR, social media, community outreach, proprietary databases, and partners.
* Experience leading patient recruitment call centers is preferable.
* Strong analytical skills, with the ability to interpret data and insights to drive informed decision-making.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
* Ideally located near Raleigh, NC, but other locations in the Central or Eastern US will be considered
* Ability to travel up to 30%.
#LI-Remote
#LI-LE1
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs.
* Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
* Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
$78k-112k yearly est. 16d ago
Manufacturing Engineer
Integrated Resources 4.5
Raleigh, NC job
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Description:
Designs, specifies and installs new equipment and provides engineering technical support and troubleshooting for all cell culture, purification and processing equipment. Provides project engineering as required for new processing equipment installations and modifications to existing equipment. Able to manage small engineering projects with little direction. Works with and provides some direction to contractors. Participates in multi-function teams to implement change and improve on existing processes.
Job Duties:
• Provides responsible engineering support for a single area of a manufacturing facility containing processing & support equipment
• Troubleshoots equipment systems and supports associated automation system troubleshooting efforts.
• Identifies and leads equipment related projects, including technology transfers, capital projects, and modifications.
• Develops and supports equipment commissioning and qualification (validation) activities.
• Maintains personal training, goal development / completion, compliance workflow tracking, & progress tracking.
• Assesses equipment needs and generates equipment user requirement specifications for fabrication or purchase
• Helps implement new manufacturing processes and technology transfers as needed for new products or modifications to existing products.
• Investigates process or equipment failures and implements changes to avoid future occurrences.
• Manages and tracks completion timelines for compliance tasks (change controls, deviation investigations, corrective & preventive actions)
• Supports creation of new procedures for equipment and systems in Engineering and Manufacturing.
Experience Requirements:
• 2 - 3 years' experience in pharmaceutical or biotech manufacturing environment
Skills and Qualifications:
• Practical knowledge and application of GMP and EMEA regulations.
• Two to three years' experience in pharmaceutical or biotech manufacturing environment
• Competency in Delta V, MS Word, MS Excel, MS Power Point and MS Project.
• Excellent oral and written communication skills.
• Ability to work rotating shifts, extended shifts and weekends as needed.
• Assignments are moderately complex in nature where ability to recognize deviation from accepted practice is required. Judgment is required in resolving problems & making routine recommendations.
• Broad understanding of the detailed aspects of the job.
• Applies job skills and company policies and procedures to complete a variety of tasks.
Qualifications
Education Requirements:
• Bachelor's Degree with a minimum of 2 - 3 years related industry experience, or an MBA/MS
Additional Information
Ankita Teja
Technical Recruiter
Integrated Resources Inc.
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Tel: 732-429-1919
Fax: 732-549-5549
$61k-82k yearly est. 3d ago
Lead IT Analyst
Integrated Resources 4.5
Raleigh, NC job
A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
This is Direct Hire with our Client
Job Description
As a member of the IT Quality & Regulatory Compliance team, the Lead IT Analyst Regulatory Compliance helps to define, plan, and perform duties that support major system development life cycle activities, including validation review and change control approval of IT systems.
PRINCIPAL DUTIES & RESPONSIBILITIES:
• Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is
• captured and reported to support validation activities.
• Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities.
• Consult on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations.
• Provide guidance, training, and support to IT personnel in their validation efforts, to ensure compliance.
• Provide quality assurance oversight for system related issues (deviations, incidents, etc.)
• Assist in the development of IT Controls.
• Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
JOB DEMANDS:
• This job requires the Quality Assurance and Validation Specialist to attend department and user meetings, system assessment meetings, trainings, and other essential tasks.
• The Quality Assurance and Validation Specialist must maintain a professional manner in representing the company and in working with its agents and associates.
• The Quality Assurance and Validation Specialist should demonstrate initiative and self-direction while also knowing when to seek assistance.
• This person must also be able to routinely schedule and complete multiple tasks and be timeline driven.
JOB IMPACT:
• The Quality Assurance and Validation Specialist's role is essential in maintaining systems that are compliant with both regulatory (e.g., FDA) and corporate requirements and good business practices.
QUALIFICATIONS:
• Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines.
• Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL.
• Excellent communication skills, both verbal and written.
• Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment.
• Knowledge of general software and database concepts.
• Experience with risk analysis and risk management practices and tools.
• Knowledge of infrastructure technology and platforms.
• The ability to work both independently and with teams at various levels in the organization.
• Excellent organizational skills and attention to detail and accuracy.
• Five or more years of experience in computerized system validation within a regulated environment
Qualifications
GxP and ERES (21 CFR Part 11 and Annex 11
Additional Information
VAIBHAV SINGH
Technical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(D) 732-429-1647
vaibhav @irionline.com | www.irionline.com (Ignore Spaces)
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year
$104k-128k yearly est. 60d+ ago
QC Associate Scientist
Integrated Resources 4.5
Sanford, NC job
A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
This position is with my direct client
Job Description
RESPONSIBILITIES:
• Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance
• Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
• Responsible for final authorization/approval/release of documentation/equipment/processes
• Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility
• Plans projects and may initiate and develop plans to ensure their timely completion
Qualifications
QUALIFICATIONS AND SKILLS NEEDED:
• WORK EXPERIENCE/SKILLS: MINIMUM: 4 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
• EDUCATIONAL BACKGROUND: MINIMUM: BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry
OR
• 1-3 years of GMP Experience.
Additional Information
Ricky Bansal
732-429-1925
$65k-95k yearly est. 60d+ ago
Purchase/Accounting Associate
Integrated Resources 4.5
Durham, NC job
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
The successful candidate will demonstrate prior success with the following:
-plan, organize, and coordinate procurement activities for one or more new analytical lab facilities
-facilitate the order, receipt, and inventory of laboratory supplies and equipment
-coordinate repair, maintenance, and calibration of laboratory equipment and instruments
-price negotiation with key suppliers for associated equipment/supplies and manage supplier selection
-Purchase supplies and equipment; researches products, prepares and analyzes bids, purchases
required items, receives shipments and verifies contents, assembles, tests and installs new
equipment and instruments; maintains, properly controls and stores a sufficient inventory of supplies
and equipment
-Monitor, control and report on expenditures to ensure compliance within established budget
-prepares cost estimates for budget recommendation
-submits justifications for budget items.
Qualifications
Ability to prioritize and manage multiple responsibilities.
Outgoing, friendly, and professional with an organized approach.
Strong attention to detail and ability to organize data.
Absolutely must be able to multi-task in a fast-paced environment
Advanced MS Office Suite skills
Preferred 3+ years of experience in a procurement role within a lab environment
Strong interpersonal & negotiation skills.
Excellent time management
Additional Information
Best Regards,
Ayushi Jain
Technical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(W) 732-549-2030 X 252
Direct 732-429-1929
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$45k-64k yearly est. 3d ago
IT Security Operations
Integrated Resources 4.5
Raleigh, NC job
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
This is Direct Hire with our Client
Job Description
Responsibilities:
• Hands on experience on security platforms such as Cisco networks, Checkpoint Firewall, Cisco ASA, Blue Coat web content filtering and Symantec anti-virus.
• Experience with Cisco ASA Firewall troubleshooting and policy change requests for new IP segments.
• Experience supporting Level 2 and Level 3 Security Issues.
• Familiarity with Protocols, such as: OSPF, ACL, NAT, SSH, HTTP, HTTPS, DNS & DHCP.
• Excellent problem solving and debugging skills.
• Superior customer service skills with non-technical users.
• Experience with VSM ticket management system.
Qualifications
Bachelor's degree
Additional Information
VAIBHAV SINGH
Technical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(D) 732-429-1647 (Tel) 732-549-2030 Ext. 225 (F) 732-549-5549
vaibhav @irionline.com | www.irionline.com (Ignore Spaces)
Gold Seal JCAHO Certified ™ for Health Care Staffing
“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year
$30k-51k yearly est. 60d+ ago
Senior Packaging Engineer
Integrated Resources 4.5
Raleigh, NC job
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description:
The Senior Package Engineer is responsible for design, development and support of package systems and processes for primary, secondary and tertiary packaging of external parenteral, solid oral dose and liquid pharmaceutical products. These activities support new and existing commercial products, Marketing initiatives, new market launches, and cost savings or to identify problems and improvements. This position will collaborate on product commercialization cross-functional project teams and continuous process improvement teams.
This position demonstrates high-level performance and delivers high-quality packaging on schedule to meet patient, company and regulatory needs. The Senior Package Engineer will maintain and develop relationships with key suppliers and assist in packaging component related problem-solving activities with these suppliers.
Evaluate and write component specifications, Packaging Instructions, Lot Packaging Records, packaging related SOPs and Work Instruction Documents. 15%
Write packaging component/equipment Test Protocols. Develop action plans to ensure that protocol tests and evaluations are completed within established timeframes. 10%
Provide full support of packaging validation, equipment, processes and materials; subject matter expert (SME) review of validation protocols 10%
Plans and executes new component introductions to CMO to ensure on time delivery of commercial product and launch supply. 10%
Troubleshoot problems with existing packaging components at CMO and coordinate component modifications with suppliers. 10%
SME representation on new product initiatives, new market launch teams and process improvement teams. 15%
Initiation and ownership of Change Controls for CMO site packaging component changes. Coordination of new artwork requests; technical review of new and modified component artwork. 25%
The Senior Package Engineer is an individual contributor with no direct reports. This position provides support for currently marketed products packaged at external sites as well as New Product Initiatives and New Markets launches. Provides Subject Matter Expert (SME) representation on cross-functional/cross-site project teams, regulatory audits and process improvement initiatives.
The Senior Package Engineer receives no instruction on routine work following initial task description determined by the Sr. Manager of Package Engineering. Provides independent technical and compliance review of peer's work prior to final management approval. Ensures personal understanding of all quality policy/systems per assigned training curriculum. Follows all work/quality procedures to ensure quality and regulatory compliance. Leads improvement and standardization of packaging on existing products with focus on quality, performance and cost effectiveness.
Self-directed and with minimal supervision, the Senior Package Engineer determines how best to manage multiple projects and tasks in order to meet challenging, shifting timelines. Develops action plans independently for new assignments or requests outside of the department. The Senior Package Engineer receives limited review of work and mentoring and is expected to work independently to meet stated and required goals/target dates.
Collaborates with other functional groups within the company. Provides technical recommendations and implements changes for packaging processes and materials. Identifies and implements best practices, packages and processes. Actively engaged with suppliers for the testing and approval of materials and components.
Maintains membership in Industry related packaging organizations such as IOPP to understand industry trends and best practices. Participates in industry group meetings, forums and cross-company benchmarking efforts.
Additional Desirable Skills:
• Knowledge of MS Project, MS Access and SAP
• Knowledge of ROW regulations
• Knowledge of Serialization requirements for the pharmaceutical industry
Qualifications
Essential Requirements:
• Requires a BS degree in Package Engineering plus minimum 7 years related work experience, preferably in a pharmaceutical environment.
• Excellent oral and written communication skills; ability to communicate effectively with all levels of management
• Attention to detail and time management skills
• Ability to work on cross functional teams
• Knowledge of GMP, GLP, CFR, USP/EP/JP requirements
• Knowledge of ISO/ASTM/ISTA standards related to packaging
• Demonstrated initiative, results oriented, willingness and ability to institute change
• Process oriented with a strong interest in continuous improvement
• Demonstrated strong analytical skills and judgment
• Experience with packaging materials such as paperboard, adhesives, inks, glass, plastics, metals, films and labels
• Experience with automated and/or semi-automated pharmaceutical filling and packaging equipment and processes
• Knowledge of packaging and labeling design/test methods, verification/validation, various statistical tools, vendor and internal auditing, and protocol/report preparation
• Proficiency with MS Word and Excel
Additional Information
Warm Regards
Harry Chaudhary
“Clinical Recruiter”
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
Direct# 732-429-1869
(BOARD) # 732-549-2030 - Ext - 207
$85k-120k yearly est. 3d ago
Analytical Chemist
Integrated Resources 4.5
Sanford, NC job
Job Description: Provides analytical support to client groups. Analytical research and development activities will include literature searches, analytical method development, test procedure writing, analytical method validation, and method transfer. Analyzes early stage prototypes, lab samples, pilot plant samples, production samples, stability samples and competitor samples. Possesses extensive knowledge of various laboratory instruments like HPLC, GC, AA, Dissolution, IC, etc. Years of Experience 0-3.
Qualifications
What will the resource be working with, or, have exposure to?:
Biohazardous Agent work (such as menigiditis, staph aureus, Lenti Virus, streph pneumoniae)
Neisseria meningitidis serogroup A,C, Y,W
Staph aureus
Strep Pneumoniae
Additional Comments Regarding Surveillance / Clearance: Potential exposure to Tetnus Toxin.
Minimal risk of exposure, but some fermentation samples potentially have active cells and/or toxin present.
Will the Resource be working with or in support of government reimbursed products?: No - government reimbursements
Please list out the (up to) top 3 critical skills:
analytical chemistry
Precision pipetting technique
Data integrity management using laboratory notebook
Will overtime be needed?: No
If Yes, how many hours of overtime (on average) per week?:
Will you consider Veteran candidates?: Yes
How many years experience are required?: 0-2 years
What is the minimum education experience required?: BS Chemistry, Biochemistry, Microbiology, Biology, or similar
Additional Information
All your information will be kept confidential according to EEO guidelines.
$46k-65k yearly est. 60d+ ago
HEDIS Nurse
Integrated Resources 4.5
Durham, NC job
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
Job Description
Candidate must have acute care experience, not managed care like nursing home.
Required Hedis Experience.
Knowledge with NCQA.
Qualifications
Prefer RN but would consider LPN.
Additional Information
Kind Regards
,
Kavita Kumari
Delivery Lead
Integrated Resources
, Inc.
IT Life Sciences Allied Healthcare CRO
DIRECT # -
732-844-8726
$47k-68k yearly est. 3d ago
Urgent job opening for Electrical Technician
Integrated Resources 4.5
Durham, NC job
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
This is a position for a major new state-of-the-art electro-mechanical machine. The candidate should have 5 or more years' experience in schematic entry and electrical assembly. The candidate must understand electrical schematics and terms. This role directly supports electrical engineers on the project. Duties: • Schematics: A primary task of the role is to generate and update electrical schematics of machines. Proficiency at schematic entry is essential. The tool Electra E7 is used; however, the candidate is not expected to have experience with this specific tool. Electra E7 is an add-on to Microsoft Visio; the candidates must be proficient with Visio. Schematics are generated from verbal discussion and / or sketches discussed with engineers. Schematics must be well organized and follow good design rules. They must be suitable for prototype and production manufacturing. • Wiring / Assembly: This role includes assembly / wiring of prototype machines. The candidate must have experience and proficiency with electrical wiring and assembly of machines. This includes troubleshooting electrical circuits and mechanical functions of devices. • Testing: Participate in device testing and verification scenarios under the supervision of lead engineers.
Qualifications
• An associate's degree in Electrical Engineering or CAD is desirable, but not required with demonstrated design capability.
• Must be proficient with Microsoft Visio (Experience with Electra E7 schematic a plus)
• Electrical wiring / assembly
• Electrical troubleshooting.
• MS Office. Associates degree in Electrical Engineering is desirable.
Additional Information
Best Regards,
Ayushi Jain
Technical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
(W) 732-549-2030 X 252
Direct 732-429-1929
www.irionline.com
Gold Seal JCAHO Certified ™ for Health Care Staffing“INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
$41k-58k yearly est. 3d ago
Validation Engineer
Integrated Resources 4.5
Durham, NC job
IRI believes in commitment, Integrity and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.
We've stayed true to our focus of finding qualified and experienced professionals in our specialty areas. Our partner-employers know that they can rely on us to find the right match between their needs and the abilities of our top-tier candidates. By continually exceeding their expectations, we have built successful ongoing partnerships that help us stay true to our commitments of performance and integrity.
Our team works hard to deliver a tailored approach for each and every client, critical in matching the right employers with the right candidates. We forge partnerships that are meant for the long term and align skills and cultures. At IRI, we know that our success is directly tied to our clients' success.
Job Description
·
Experience in a
sterile or pharmaceutical environment
is required but will consider other FDA -- cGMP experience and medical device or combination product production
·
Performed validation of
Quality Control laboratories instruments
(with and without computer systems) according to the site's applicable validation SOPs.
·
Authors validation deliverables as required.
·
Ensure that the system is installed and configured in a
21 CFR Part 11/Annex 11
compliant manner.
·
Provide validation expertise and support to
the Quality Control laboratories.
·
At least 4 years' experience
validating equipment
·
At least 2 years' experience
validating laboratory instruments with computer systems
·
Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories.
·
Authors cGMP risk assessments, user requirements and function specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs. Previous experience with validation of laboratory instrument systems preferred.
·
Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed.
·
Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans.
·
Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and
CAPA to ensure compliance and validated state of the instrument.
·
Previous experience with PR/CAPA systems preferred.
·
Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies to mitigate the gaps.
·
Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments.
·
Support and assist teammates wherever possible.
·
Perform other related duties as assigned or required.
·
Quality Laboratories Subject Matter Experts for the respective instruments
·
Quality Laboratories System Owners for the respective instruments
·
Quality Laboratories System Super Users (if applicable) for the respective instruments
·
Instrumentation Team (if applicable) for instrument calibration
Additional Information
Regards,
Indu
Clinical Recruiter
732-844-8725
indu @irionline.com