Quality Associate II Job at Katalyst Healthcares & Life Sciences, New York, NY

aGYxbnpna1lHb2tFYWhnL2xBR0VWT3pXM1E9PQ==
  • Katalyst Healthcares & Life Sciences
  • New York, NY

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Job Description

:

  • This document outlines the employment prerequisites and job responsibilities for the Supplier Quality Associate II position.
  • This position has primary responsibility for driving overall quality performance throughout the supply chain.
  • Specific responsibilities include:
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, and process controls for both critical sustaining parts and new products.
  • As required, participate as an active member in the new products development team.
  • Perform and coordinate supplier: surveys, quality system, and process control assessments.
  • Work with purchasing to measure and communicate supplier performance on key metrics and the corresponding continuous improvement plans.
  • Collaborate with supplier representatives in establishing effective quality systems, process controls, and problem-solving methodologies.
  • Conduct process and component validations as applicable.
  • Monitor and drive corrective action and continuous improvement activities that directly impact performance for assigned suppliers.
  • Conduct or lead event investigations and root cause analyses relative to purchased materials and components.
  • Perform other duties as assigned.

Responsibilities:

  • Knowledge & application of reading and understanding blueprints/technical drawings.
  • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
  • Experience in manufacturing/quality assurance engineering in an FDA regulated environment.
  • Knowledge and working application of standard operating procedures.
  • Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
  • Knowledge and working application of data entry and spreadsheet applications.
  • Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
    Practical experience in metrology, test equipment, inspection and analysis techniques.
  • Desired experience is in the medical device industry development and deployment of Quality System and process controls and continuous improvement methods (QSR, ISO13485).
  • Desired CQE, CSSBB, CQA or initiative to complete certifications.
  • Primary/Secondary party compliance auditing experience.
  • Ability to multi-task and methodically manage projects.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Effectively operate in and facilitate cross-functional teams with guidance.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.
  • Ability to: stand or walk for long periods, lift and carry at least 20 pounds, perform repetitive motions with hands/fingers.
  • Demonstrated strong analytical problem solving (CAPA), teaming, and communications/interpersonal skills.
  • Must be willing to travel as needed.

Requirements:

  • Bachelor's Degree required.
  • Lead Auditor training, ISO Lead Assessor training, with 1-2 years' experience in auditing techniques, interpreting regulations and quality systems.
  • Minimum of 3-5 years of experience in Quality, or related field in the medical products industry.
  • Physical Demands
    Able to exert up to 10 pounds of force occasionally. Able to sit, stand, walk throughout the workday.
  • Work Environment
    Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
  • Always wearing a static protective smock while in the manufacturing work area.
  • Working near other employees.
  • Working in an environment that is temperature and humidity controlled.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

Similar Jobs

Suzhou Pine Forest network Technology Co,Ltd

German and Russian Translator needed Job at Suzhou Pine Forest network Technology Co,Ltd

one German and Russian Translator neededSuzhou Pine Forest network Technology Co,Ltd company located in Suzhou city ,Zhegjiang province and its main business is to develop the network game . Right now the company has already set up the branch at Shanghai,,the US , German... 

SMARTECH and Associates, LP

Tier 2 Computer Hardware Field Technician Job at SMARTECH and Associates, LP

 ...Computer Technician-Conover, NC Immediate need to hire Conover and surrounding areas. IMMEDIATE NEED TO HIRE COMPUTER HARDWARE TECHNICIAN. WHAT WE DO: ~ Hardware Replacement/Repair: Desktops, Laptops, Servers, Printers, and POS systems. Why Join Us?... 

OPNX

Data Entry Clerks - multiple positions (June 2023) Job at OPNX

Why work for OPNX? The company is soon to be global cryptocurrency...  ...for detail-oriented Data Entry Clerks to join our team. The...  ...Requirements: - No prior experience is required, however a basic...  ...benefits Location: Work from home Salary: Negotiable based on... 

Addus Homecare

Home Care Aide Job at Addus Homecare

Now offering DAILY PAY for select positions!Addus HomeCare is hiring immediately for Home Care Aides. This rewarding, entry-level position provides consistent, flexible full time/part time hours to accommodate your personal needs, while providing a great career with a... 

Kah Landscaping

Landscape Designer Job at Kah Landscaping

 ...Kah Landscaping, with over 74 years of experience, is recognized for creating exceptional outdoor environments that blend artistry and functionality. As a Landscape Designer, you will have the opportunity to bring creative visions to life, working closely with clients...