Write and review designated Standard Operating Procedures, Change Control Plans, Validation Plans, Test Cases, and Validation Summaries.
Responsibilities:
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Review and observe processes that are performed or will be performed in Technical Services in anticipation of writing documents that accompany these processes.
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Write specific documents including, but not limited to, Standard Operating Procedures, Change Control Plans, Validation Plans, Test Cases, and Validation Summaries.
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Meet and exceed employee program expectations of AMO CommYOUnity! standards: Rewards & Recognition, Communication, Individuality, Integrity, Respect, and Pursuit of Excellence.
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Complete special projects as assigned.
Skills, Education, & Experience:
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High School diploma or equivalent, college degree strongly preferred.
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Technical writing experience required.
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Strong Knowledge of blood banking and cGMP in a regulatory environment.
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Communicate effectively in writing as appropriate for the needs of the audience.
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Familiarity with personal computers, Microsoft Word, Microsoft Excel, and RingCentral video calls.
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Knowledge of AABB and FDA regulations.
Physical/Mental Abilities:
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Demonstrated ability to be detail oriented.
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Able to communicate information and ideas in writing so others will understand
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Ability to train other staff in these procedures as necessary
