RockyMountRecruiter Since 2001
the smart solution for Rocky Mount jobs

Lab Instumentation Validation Specialist

Company: Net2Source Inc.
Location: Rocky Mount
Posted on: November 5, 2019

Job Description:

Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring " Validation Engineer II " for one of our clients . We offer a wide gamut of consulting solutions customized to our 450 clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering. Job Title: Validation Engineer II Duration: 03 Months Location: Rocky Mount, NC ROLE RESPONSIBILITIES --- Serves as validation representative for laboratory instruments and partners with the laboratories, Quality System Administrators, Business Technology, Instrumentation and Quality Engineering on implementing new instruments at the site. --- Initiates and leads risk assessment, gap analysis and deviation management for commissioning of, changes to or decommissioning of laboratory instruments and associated instrument control software where applicable within the Quality Laboratories. --- Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs. --- 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 with core stake holders to mitigate the gaps. --- Assists the system owner with evaluating and recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and setting up preventive maintenance plans. --- Previous experience with Trackwise PR/CAPA systems preferred. --- Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed. Top 5 Skills -Requirement: 1. Validation of laboratory instruments including those with computer system attached for instrument control (i.e. AA, FT-IR, ICP-MS, TOC, UV_Vis) 2. Experience with configuring, testing and validating the laboratory systems to demonstrate compliance with 21 CFR Part 11/Annex 11 as well as proposing procedural controls if the system is unable to fully meet the requirements 3. Hands on experience operating the instrument systems to be able to write test scripts to demonstrate the essence of the Part 11 regulations which is to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. As such the electronic records should not be susceptible to unauthorized access, alteration/modification, deletion, or other methods of falsification and the audit trail must capture changes. These records need to be accurate and be accessible/available for the duration of data retention period in case it is needed for regulatory or other audits. About Net2Source, Inc. Net2Source is an employer-of-choice for over 2200 consultants across the globe. We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. We are one of the fastest-growing companies in the U.S. and this may be your opportunity to join us Want to read more about Net2Source?, Visit us at Equal Employment Opportunity Commission The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor. Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 2200 employees globally and 30 locations in US and operations in 20 countries. With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs. We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services. Fast Facts about Net2Source: --- Inception in 2007, privately held, Debt free --- 2200 employees globally --- 375 In- house Team of Sales, Account Management and Recruitment with coast to coast COE. --- 30 offices in US and 50 Offices globally --- Operations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia) Awards and Accolades: --- 2018 - Fastest Growing IT Staffing Firm in North America by Staffing Industry Analysts --- 2018 - Fastest-Growing Private Companies in America as a 5 times consecutive honoree - Inc. 5000 --- 2018 - Fastest 50 by NJBiz --- 2018 - Techserve Excellence Award (IT and Engineering Staffing) --- 2018 - Best of the Best Platinum Award by Agile1 --- 2018 - 40 Under 40 Award Winner by Staffing Industry Analysts --- 2018 - CEO World Gold Award by SVUS --- 2017 - Best of the Best Gold Award by Agile1 Warm Regards Monika Thakre Team Lead - Net2Source Office: (201) 340-8700 x 454 - Cell: 201-331-8567 - EmailOffice: (201) 340-8700 x 454 - Cell: 201-331-8567 - Email :

Keywords: Net2Source Inc., Rocky Mount , Lab Instumentation Validation Specialist, Healthcare , Rocky Mount, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Healthcare Jobs


Physical Therapist Assistant (PTA) - PRN
Description: Overview br At HealthPro Heritage we hire people who share our vision, who work diligently and provide the kind of care that will help change patient's lives for the better. As an Associate, your dedication (more...)
Company: Healthpro Heritage
Location: Raleigh
Posted on: 11/22/2019

RN / Registered Nurse / North Carolina / Any / Family NP - Outpatient
Description: Specialty: Family Nurse Practitioner Location: Raleigh, North CarolinaShift: Ongoing per diemJob DetailsFocus on patients and help them achieve better health in onsite corporate
Company: All Medical Personnel
Location: Raleigh
Posted on: 11/22/2019

Travel Nurse RN - OR - Operating Room - $1,669 per week
Description: NurseFly Travel Nursing with KPG Healthcare is seeking a or - operating room travel nurse for a travel nursing job in Raleigh, North Carolina: - Specialty: OR - Operating Room - Discipline: RN - Start (more...)
Company: NurseFly Travel Nursing
Location: Raleigh
Posted on: 11/22/2019


RN / Emergency Room
Description: The benefits of taking a travel nursing job with Cross Country Nurses include: Free Private Housing or Generous Housing Allowance Comprehensive Health Insurance with Prescription Coverage Dependent
Company: Cross Country Healthcare
Location: Raleigh
Posted on: 11/22/2019

Travel RN ICU, MICU - Medical Intensive Care Units
Description: Travel Nurses Needed - RN Intensive Care UnitsMassachusetts Travel Nursing AssignmentsNationwide Registered Nurse Travel JobsThe Travel Nurse Season is here and it showsFind great travel assignments with (more...)
Company: HealthCare Travelers (Nursing)
Location: Raleigh
Posted on: 11/22/2019

Physician / Surgery - Orthopedics / North Carolina / Permanent / USE Y
Description: Requirements include:- Doctor of medicine or doctor of osteopathy degree from an accredited U.S. school of medicine or osteopathy foreign graduates may apply if they have a permanent certificate from (more...)
Company: USAREC 2MRBn
Location: Raleigh
Posted on: 11/22/2019

Skilled Nursing Facility Travel LPN / LVN (SNF)
Description: Nationwide Travel Nurse Jobs - Medical Surgical Med Surg Licensed Practical NurseHCEN client agency who has put in a special request to fill numerous Nationwide LPN / LVN Nursing vacancies. br ul (more...)
Company: HealthCare Traveler Jobs
Location: Raleigh
Posted on: 11/22/2019

Registered Nurse Tele RN - Travel Assignments
Description: Travel RN Nursing JobsRegistered Nurses needed for:South Dakota--Travel Tele, PCU, CCU, StepdownNursing JobsHCEN has numerous request for RN CandidatesThe Travel Nurse Season is here and it shows--The (more...)
Company: HealthCare Travelers (Nursing)
Location: Raleigh
Posted on: 11/22/2019

Travel Nurse RN - CVICU - $1,551 per week
Description: NurseFly Travel Nursing with Travel Nurse Across America is seeking a cvicu travel nurse for a travel nursing job in Raleigh, North Carolina: br br br ul br li Specialty: CVICU br li Discipline: (more...)
Company: NurseFly Travel Nursing
Location: Raleigh
Posted on: 11/22/2019

Skilled Nursing Facility Travel LPN / LVN (SNF)
Description: Nationwide Travel Nurse Jobs - Medical Surgical Med Surg Licensed Practical NurseHCEN client agency who has put in a special request to fill numerous Nationwide LPN / LVN Nursing vacancies. br ul (more...)
Company: HealthCare Traveler Jobs
Location: Durham
Posted on: 11/22/2019

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Rocky Mount RSS job feeds