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Quality Assurance Specialist in Holliston, MA at CoWorx Staffing Services

Date Posted: 9/25/2018

Job Snapshot

Job Description

CoWorx Staffing is hiring for a manufacturing facility in Holliston. The Quality Assurance Specialist is responsible for performing daily quality reviews by ensuring quality compliance, policies, industry standards, and applicable regulations. Perform documentation review activities (e.g., incoming inspection records,    

batch records, shipping documentation, equipment and maintenance documentation, 

various logs and forms, etc.)   Duties and Responsibilities:

  • Performs status labeling of raw materials, finished products, etc.,            
  • 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

Job Requirements

  • 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)
  • Experience using eQMS and ERP required or equivalent paper based systems         
  • 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 

Benefits

At CoWorx, we are committed to assisting our employees on the road to professional success. We are a highly reputable organization that takes care of its employees by offering a variety of health benefits. We work hard to find the best possible fit for you and our client. We offer bonuses and extra incentives such as an Employee of the Month Award and other employee appreciation rewards and events

Benefits of the Assembler role include:

•         Medical, Dental, Vision

•         Prescription Plan

•         Short-term Disability

•         Life Insurance

•         401(k) Retirement Plan

•         Program Rewards Bonus

•         Referral Bonus Program

•         Direct Deposit

•         Debit Account

•         Software Training & Tutorials

•         Resume Assistance

•         Interviewing Tips Awards