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QA Specialist Shop Floor

Job Attributes

Job Id:

29354

Job Category:

Clinical & Life Sciences

Job Location:

Summit, NJ  07901

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

Piper Companies is currently looking for a Quality Assurance Shop Floor Specialist in Summit, NJ to work in a growing and innovative bio pharmaceutical manufacturing company

Responsibilities for the Quality Assurance Shop Floor Specialist Include:

  • Draft, revise, review, route, and approve SOP's, Work Practices, Forms, and other type of GMP documentation 
  • Responsible for routing document deliverables through the Document Management system
  • Assist in the writing of deviations, CAPA's, and Change Controls
  • Responsible for periodic reviews of SOP's
  • Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
  • Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
  • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
  • Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
  • Follows up with team members and cross functional team members to encourage timely review and approval.

Qualifications for the Quality Assurance Shop Floor Specialist Include:

  • Highly proficient in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database system
  • Understands and works with all components related to web pages, i.e., web parts, lists, pages, libraries, permissions, content and forms
  • Strong working knowledge in computer training systems
  • Working knowledge of enterprise business systems such as Oracle or SAP
  • Strong written and verbal communication skills
  • Experience with technical writing and document development / generation
  • Excellent interpersonal skills with experience dealing with a diverse workforce
  • Strong multi-tasking ability in conjunction with proven organizational skills
  • Familiarity with FDA and EU environments and associated compliance regulations

Compensation for the Quality Assurance Shop Floor Specialist Includes:

  • Compensation commensurate with experience 
  • Full Benefits: Medical, Dental, Vision, 401(k) plan, Holidays, PTO

 

Keywords:

Quality assurance, Shop Floor, Specialist, QA, QC, quality control, GCP, GMP, CGMP, FDA, regulatory, quality management, pharmaceutical, pharma, combination device, biotechnology, regulatory, benefits, vacation, holiday, 401(k)

 

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New Search

Job Id:

29354

Job Category:

Clinical & Life Sciences

Job Location:

Summit, NJ  07901

Security Clearance:

No Clearance

Business Unit:

Piper Companies