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Documentation Specialist
Ref No.: 19-16291
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Documentation Specialist in Swiftwater, PA with one of our top client.
Job Title: Documentation Specialist
Job Id: 19-16291
Location: Swiftwater, PA 18370
Duration: 12 months
Position Type: Hourly contract Position (W2 only)
  • Maintaining and coordinating the Record Retention process of GMP documents for the Antigen Platform.
  • This responsibility includes onsite and offsite record retention.
  • Creation and control of Production logbooks pre, post and during use.
  • Maintaining document control through Production Floor Support, including but not limited to exchanging inactive official copies of documents for active official copies of documents in real time.
  • Supporting production needs by being responsible for performing administrative tasks such as gathering and preparing documentation to support investigations, operational optimization and/or change controls/CAPAs
  • Ensure cGMP regulations regarding documents, logbooks and forms are adhered at all times for the Antigen Vaccine Platform.
  • Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
  • Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
  • Experience: 0-3 years
  • Attention to details
  • Able to gown aseptically multiple times throughout the course of a day.
  • Working knowledge of cGMP is required
  • Good Communication skills both written and verbal
  • Proficiency in WORD, and EXCEL, and have a working knowledge of other MICROSOFT OFFICE programs.
  • Excellent organizational skills.
  • Sound interpersonal and information gathering skills, being able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
  • Work quickly with a high degree of accuracy.
  • Technical Writing experience preferred
  • Previous experience working within a production department of a pharmaceutical company preferred
  • Candidate must be able to work extended and flexible hours (including weekends) when needed. 
  • Bachelor’s Degree preferred but not required. 
Skills and Experience
  • Administrative Tasks
  • CGMP
  • Document Control
  • Documentation
  • Excel 
Additional Skills
  • Excellent Organizational Skills
  • Microsoft Office
  • Optimization
  • Organizational Skills
  • Real Time
  • Word
  • Writing Experience
  • Excellent Written and Verbal Communication Skills GMP Microsoft Excel Microsoft
  • Word 
Pooja Sinha
Direct: (732) 272 - 0316 | Email:
Satya S
Direct: (732) 272.0262 | Email: