Documentation Specialist I

  • location: Swiftwater, PA
  • type: Contract
  • salary: $19.43 - $22.86 per hour
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job description

Documentation Specialist I

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Swiftwater, Pennsylvania
job type: Contract
salary: $19.43 - 22.86 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • 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.
 
qualifications:
Education & Qualifications

  • Bachelors Degree preferred but not required.
  • 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.
  • Experience: 0-3 years
 
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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