QA Document Specialist

Zachary Piper Solutions, LLC
Raritan, NJ Full Time
POSTED ON 5/5/2023 CLOSED ON 5/31/2023

What are the responsibilities and job description for the QA Document Specialist position at Zachary Piper Solutions, LLC?

Job Description

Piper Companies is currently seeking a Quality Documentation Specialist based in Raritan, New Jersey for work at a leading pharmaceutical company. The Quality Documentation Specialist will assist in the revision and completion of all documents-SOPs, work practices, all other types of GMP documentation-while ensuring timeliness and overall audit preparedness.

Responsibilities of the Quality Documentation Specialist:
  • Support quality assurance operations
  • Draft, revise, route and approve SOPs, work practices, protocols, other GMP documentation deliverables
  • Route materials through in-house document management system
  • Assist with inspection readiness and qualification/verification/validation
  • Maintains the documentation files in compliance with ISO 13485, FDA 21CFR 820 and 21 CFR Part 11, EU Medical Device Regulations 93/42/EEC, and EU MDR/2017

Qualifications of the Quality Documentation Specialist :
  • 2 years QA experience or laboratory documentation experience
  • Experience with analytical techniques such as PCR, immunoasssays, gel-based assays
  • Proficient in Microsoft Office Suite; some experience with MasterControl/Veeva/Documentum preferred

Compensation for the Quality Documentation Specialist:
  • Commensurate with experience, multiple openings, $34/hr
  • Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO

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Salary : $34 - $0

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