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QA Specialist II
$74k-91k (estimate)
Contractor | IT Outsourcing & Consulting 4 Weeks Ago
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TalentBurst, an Inc 5000 company is Hiring a QA Specialist II Near Des Plaines, IL

Job Title: Quality Assurance Specialist II
Location: Des Plaines IL, 60018
Duration: 12 months (possibility to extend)

MAIN RESPONSIBILITIES
  • Familiar and capable of performing all responsibilities of the Quality Associate.
  • Subject Matter Expert in one or more specific Quality processes such as incoming inspection and/or change management and/or records (including batch release).
  • Also support record administration and batch record review, including Certificate of Analysis / Certificate of Conformance creation for material lot release.
  • Assign labeling and pre-production change requests to Change Management staff aligning experience with project load and complexity.
  • Process IUO and IVD product labeling and the associated RMS change requests while ensuring compliance with company policies and procedures.
  • Able to navigate complexity and troubleshoot issues with the most complex changes.
  • Assist labeling change owners and junior staff with the creation of design change plans.
  • Able to leverage subject matter expertise to impart positive impacts on organizational outcomes.
  • Support change packets per the approved procedures, including analyzing change packets for impact to Device Master Records and for the associated maintenance of the DMRs.
  • Able to independently correct issues and proactively identify future issues.
  • Leverage expertise to improve future submissions via collaboration with change owners.
  • Create and maintain the Design History Files per the approved procedures.
  • Review records for good DHF documentation practices and adherence to the DHF Document Change Control requirements.
  • Maintain the Master Action Item List, DHF Index and the DHF History Index.
  • Assist in the documentation of key processes and departmental procedures and well as participate on continuous improvement projects as assigned.
  • Compiles and maintains data used for the creation of department metrics and reports. Able to own key local reporting responsibility and take the lead in areas of expertise, as appropriate.
This position is NonExempt. Hours over 40 will be paid at Time and a Half. Assures the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices). BS degree or 3-7 years equivalent experience


TB_PH

Job Summary

JOB TYPE

Contractor

INDUSTRY

IT Outsourcing & Consulting

SALARY

$74k-91k (estimate)

POST DATE

05/30/2024

EXPIRATION DATE

10/06/2024

WEBSITE

talentburst.com

HEADQUARTERS

BOURNE, MA

SIZE

25 - 50

FOUNDED

2002

CEO

JOE CLERICO

REVENUE

<$5M

INDUSTRY

IT Outsourcing & Consulting

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About TalentBurst, an Inc 5000 company

TalentBurst is a certified MBE staffing/payroll firm founded in 2002 by 3 ex-Monster.com executives. We provide award winning solutions for the Global Talent Cloud including: IT, Engineering, Professional, & F&A Staffing Life Sciences & Clinical Staffing High Hazard & Global Payroll 1099/IC Validation & Compliance Our MSP partners & end customers have recognized us with the following awards: AgileOne Gold Supplier 2017 Allegis Global Solutions Strategic Partner 2018, 2019, 2020, 2021 Allegis Global Solutions Diversity Partner of the Year 2020 Geometric Results Platinum Preferred Partner KellyO ... CG #1 Strategic Supplier @ #1 Cloud Computing PRO Unlimited Silver, Gold, & Platinum Supplier 2012 - 2020 Randstad Premier Supplier 2021 TAPFIN Premier Partner 2017, 2018 TAPFIN Program Performance Award @ #1 cloud computing Workforce Logiq Proven Performer 2016 - 2020 First Data #1 supplier for 12 Quarters Thermo Fisher Supplier of the Quarter Toyota Best in Compliance and Retention Excellence Dominion Energy Supplier of the Year 2020 Western Union Supplier of the Year 2017 2020, 2021 BBJ Fast50 10 time BBJ "Pacesetter & INC 500/5000 5 time SIA-fastest growing SIA 2020 Large Life Sciences Staffing Firms GENMSDC "Supplier of the Year" Category 4 2019, 2020 Top 3 Supplier for Sanofi, Visa, Adobe, Securian Top Supplier for First Data for 10 years We currently have workforce in 46 states and 8 countries working for customers such as Amazon, Uber, VISA, Exelon, Securian, Salesforce.com, Dropbox, Twitter, Verizon Media, Adobe, Western Union, First Data, FIS, National Grid, SANOFI, Merck, Abbott, Roche, Symantec, and Corning among many others. We are headquartered in Natick, MA along with operations in San Fran, CA; Fort Lauderdale, FL; Vineland, NJ; Providence, RI, Raleigh, NC, Toronto, Canada; & Gurgaon, India as well as remote Executives strategically placed nationwide. Please check us out at www.TalentBurst.com or via Linkedin or Facebook. More
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