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Documentation Specialist
Ref No.: 19-07964
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: 19-07964
Location: Swiftwater, PA 18370
Duration: 11 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • Manager requires some relevant experience. Budget is firm at the rate card minimum (USD)32.25
  • Maintaining and coordinating the Record Retention process of GMP documents for the Viral Platform.
  • This responsibility includes onsite and offsite record retention.
  • Creation and control of Production logbooks pre, post and during use.
  • Creation and control of cGMP forms.
  • 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 and continuous improvement including change control, CAPA implementation, and operational optimization.
  • Coordinating document revisions between multiple groups to ensure Right the First Time environment, open communication, and to reduce the probability of rework and/or missed work.
  • Ensure cGMP regulations regarding documents, logbooks and forms are adhered at all times for the Antigen Vaccine Platform.
  • Experience: 0-3 years
  • Attention to details
  • Working knowledge of cGMP
  • 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. 
Education
  • Bachelor’s Degree preferred but not required. 
Required Skills
  • CAPA
  • CGMP
  • Change Control
  • Documentation 
Additional Skills
  • Excel
  • GMP
  • Microsoft Office
  • Optimization
  • Real Time
  • Word
  • Corrective and Preventive Action
  • Document Control
  • Excellent Organizational Skills
  • Excellent Written and Verbal Communication Skills Microsoft Excel Microsoft Word Organizational Skills. 
Contact
SUNNY RAJPUT
DIRECT: (732) 272 0302 | EMAIL: SUNNY.R@SUNRISESYS.COM
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com