Documentation Specialist I

Swiftwater, PA

Posted: 06/07/2019 Industry: Quality Assurance/Safety Job Number: 49025

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

Skills: Attention to details Working knowledge of cGMP Good Communication skills both written and verbal

Proficiency in WORD, and EXCEL, and have a working knowledge opf 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:

Bachelors Degree preferred but not required.


Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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