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Quality Assurance Specialist 1

Holliston, MA 01746

Employment Type: Contract Industry: Manufacturing Job Number: 49910

Quality Assurance Specialist 1

A client of ours is seeking an experienced and forward-thinking individual to join a growing  team!

The Quality Assurance (QA) Specialist I is responsible for performing daily quality reviews by ensuring quality compliance in accordance with Web Industries policies, industry standards, and applicable regulations.

Performs documentation review activities:
  • Incoming inspection records
  •   Batch records
  • Shipping documentation
  • Equipment and maintenance documentation
  • Various logs and forms
  • Performs status labeling of raw materials and  finished products
  • Assists with filing and retrieval of documents (both physical and electronic) within the Document Control Center 
  • Participates in non-conformance, deviation, or complaint investigations
  • Revises, reviews, or approves controlled documents
  • Supports verification of any critical inspections or tests as needed in relating to incoming, production, and/or validation activities
  • Supports Quality training programs
  • Provides direct support of second and third party audits
  • Participates in internal audits as needed

Bachelor’ s degree in a scientific or analytical discipline and 1 year experience in a FDA-regulated industry -- or— high school diploma and 3 years’ experience in a FDA-regulated industry
  • Minimum of 1 year experience working in an FDA-regulated (Medical Device, Pharma, and/or Biologics) or medical device certified (ISO 13485) manufacturing environment preferred
  • Experience using eQMS and ERP required or equivalent paper based systems
  • Knowledge of CFR (11, 803, 806, 809, 810, 820) as well as ISO 13485 and 14971 preferred
  • Working knowledge of GDP (Good Documentation Practices)
  • Strong attention to detail and ability to review for compliance, accuracy and completeness
  • Ability to prioritize and manage multiple tasks and changing priorities
  • Strong communication, writing skills, and organization skills required with ability to work in a team environment
  • Experience with Microsoft Office suite and Visio
  • Experience in CMO environment preferred
  • Experience with data analysis and statistical methods is a plus
  • Ability to work in an office and production environment required (sitting, standing, working at a computer)

 

U.S. citizenship or permanent residency required

Don' t feel you are the best fit for this job but know someone who is? Refer someone who is hired for this role (or ANY other) and we will offer you a referral bonus for helping us to keep our client happy.

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