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Documentation Specialist I

Ascent

Job Description

Documentation Specialist
Swiftwater, PA
1 Year Contract
 
Summary:
Maintaining and coordinating the Record Retention process of GMP documents for the Antigen Platform.
 
Responsibilities:
  • 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.
Requirements:
  • 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.

Job Requirements

 
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Job Snapshot

Location US-PA-Swiftwater
Employment Type Full-Time
Pay Type Hour
Pay Rate N/A
Store Type Other

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Terms & Conditions
Snapshot
Ascent
Company:
US-PA-Swiftwater
Location:
Full-Time
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

Documentation Specialist
Swiftwater, PA
1 Year Contract
 
Summary:
Maintaining and coordinating the Record Retention process of GMP documents for the Antigen Platform.
 
Responsibilities:
  • 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.
Requirements:
  • 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.

Job Requirements

 
Documentation Specialist I Apply now