Talent.com
Omni Inclusive
Quality - Quality Records SpecialistOmni Inclusive • Summit, NJ, United States
Quality - Quality Records Specialist

Quality - Quality Records Specialist

Omni Inclusive • Summit, NJ, United States
1 day ago
Job type
  • Full-time
Job description

Global Supplier Quality, External QC Quality Records

Location: Summit, NJ

Purpose And Scope Of Position: The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include; coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.

Required Competencies: Knowledge, Skills, and Abilities:

  • Experience with deviation and change control management, preferably with Infinity systems
  • Strong organizational skills, including ability to follow assignments through to completion
  • Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects
  • Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams
  • Detail oriented with demonstrated application in problem solving
  • With moderate oversight from manager, think strategically and understand global impact of decisions

Duties And Responsibilities:

  • Initiation, facilitation, and tracking of quality records
  • Provide regular communication and metrics for status of quality records
  • Effectively communicate issues, risks and proposed solutions within the organization
  • Provide communication, support, and guidance to CTLs within the QA vector and upstream material team
  • Working closely with other GSQ QC members to submit and track sample material for testing at CTL
  • Create and revise SOP
  • Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)
  • Enter data and retrieve information from Sharepoint and Smartsheet testing trackers

Working Conditions (US Only): May be required to work in office environment. Sitting, standing and computer work is required. Ability to participate in conference calls.

Create a job alert for this search

Quality - Quality Records Specialist • Summit, NJ, United States

Similar jobs

Consumer Opinion Research Participant

GL IncTwin Rivers, New Jersey
$15.00 hourly
Part-time +1

Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies.We guarantee 15-25 hours per week with an hourly pay of bet... Show more

 • Promoted

Compliance Specialist - Non Exempt

TTI of USASummit, NJ, United States
Full-time

Compliance Specialist, Equipment Commissioning & Qualification.The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and bus... Show more

 • Promoted

Quality Improvement Specialist

Hackensack Meridian HealthHolmdel, NJ, United States
Full-time +1

Quality Improvement Specialist.The Quality Improvement Specialist acts in conjunction with the Regional Chief Quality & Safety Officer, HMH Vice President Clinical & Nursing Quality, HMH Patient Sa... Show more

 • Promoted

International Trade Services Specialist Sr. - Letters of Credit

PNCEast Brunswick, NJ, United States
Full-time

International Trade Services Specialist Senior.At PNC, our people are our greatest differentiator and competitive advantage in the markets we serve.We are all united in delivering the best experien... Show more

 • Promoted

Specialist, Regulatory and Compliance

QPharma, Inc.Morristown, NJ, United States
Full-time

QPharma is currently looking for a Regulatory and Compliance Specialist for our Cedar Knolls, NJ location.Responsibilities include but are not limited to:Quality Management Systems:Manages the proc... Show more

 • Promoted

Raw Material Quality Auditor

FerreroParsippany, NJ, United States
Full-time

Job Location:Parsippany, NJAbout the Role:We have a current opening for a Raw Material Quality Auditor and are actively reviewing applications.The Raw Material Food Safety & Quality Auditor ens... Show more

 • Promoted

Document Prep Specialist 1

Randstad@WorkFreehold, NJ, United States
Full-time

Salary:$17 per hour none Reference:1132959-14 Job Description:Normal Work Schedule:5 days a week, 9 hours a day including 30-minute lunch and two 15-minute breaks.Evening and 3rd shift may be requi... Show more

 • Promoted

Certified Medical Assistant

New Jersey UrologyEast Brunswick, NJ, United States
Full-time

The role of the Medical Assistant is to provide both administrative and clinical support to the clinics.The Medical Assistant must be able to work independently as well as interact as part of a tea... Show more

 • Promoted

Director of Quality and Clinical Excellence

Complete Care ManagementEdison, NJ, United States
Full-time

Director Of Quality And Clinical Excellence.The Director of Quality and Clinical Excellence leads the NJPCS Quality Program, which includes two connected areas: Audit and Compliance and Clinical Co... Show more

 • Promoted

Quality Assurance Specialist

DHD ConsultingMonroe Township, NJ, United States
Full-time

Monroe Township, New Jersey, United States.About the Job Quality Assurance Specialist.Support daily QA operations related to document control, change control, training, and CAPA management.Review a... Show more

 • Promoted

Internal Auditor II/ Global Medical Quality Specialist

Connecting Talent 2 OpportunityMorristown, NJ, United States
Full-time

Medical Quality Support Specialist.To provide quality support specific in GxP Medical activities (e.Incumbent will support Medical Quality Business Partner on medical quality activities to include ... Show more

 • Promoted

Staff Quality Systems Specialist

BD (Becton, Dickinson and Company)Franklin Lakes, NJ, United States
Full-time

Job Description SummaryThe Staff Quality System Specialist is accountable for the support of the continued development, improvement, implementation of the Quality Management System as well as maint... Show more

 • Promoted

Senior Documentation Specialist

SGAMadison, NJ, United States
Full-time +1

Software Guidance & Assistance, Inc.Documentation Specialist for a Contractassignment with one of our premier Pharmaceutical Services clients in Madison, NJ.Responsibilities:Review document fol... Show more

 • Promoted

Director of Quality

PIM BrandsSomerset, NJ, United States
Full-time

Salary Education Level 4 Year Degree.Do you love snacks? Are you looking to join an ever evolving and rapidly growing team? PIM Brands might just be exactly what you're looking for!.At PIM, We Make... Show more

 • Promoted

CAPA Program Lead

Katalyst Healthcares & Life SciencesSomerset, NJ, United States
Full-time

Our client is a leading medical device company and is seeking an experienced CAPA Program Lead to lead a high-priority quality remediation initiative supporting medical device regulatory compliance... Show more

 • Promoted

Performance Improvement Coordinator

Saint Peter's Healthcare SystemNew Brunswick, NJ, United States
Full-time

Performance Improvement Coordinator.The Performance Improvement Coordinator will:.Serve as a resource to Department/Committee Chairmen and Department Managers.Analyze information provided by intern... Show more

 • Promoted

Director Commercial Quality US

Teva PharmaceuticalsParsippany, NJ, United States
Full-time

Director Commercial Quality US.The Director Commercial Quality US is responsible for the Commercial Quality activities in the United States, covering the responsibilities of the US Quality Systems ... Show more

 • Promoted

Project Controls Specialist

TALENT Software ServicesNewark, NJ, United States
Full-time

Develop, maintain, and report on program budgets, forecasts, and performance dashboards.Prepare monthly spend plans, accruals, and cost summaries for client reporting.Support KPI tracking, performa... Show more

 • Promoted

Regional Performance Excellence Leader

CorbionTotowa, NJ, United States
Full-time

Regional Performance Excellence Leader.At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.Our Manufacturing Performance Exce... Show more

 • Promoted

Remote Patient Accounts Quality & Systems Analyst

University of Chicago Medical CenterUnion, NJ, United States
Remote
Full-time

A leading healthcare institution is seeking a Patient Accounts Operations / Systems Quality Analyst to join their Revenue Cycle Department.This full-time position offers a flexible work-from-home o... Show more