Specialist Quality Control

: Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.

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Resolve technical issues and troubleshoot for assays as necessary.

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Ensure lab compliance : which includes implementing procedures that enhance GMP, GLP and safety.

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Manage existing and/or develop and implement new programs, processes and methodologies.

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Develop, revise and audit various complex controlled documents that may have multi:organizational and/or multi:site impact.

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Approve lab investigations.
Requirements

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Excellent technical writing skills.

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Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.

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Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion.

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Extensive knowledge and application of GMPs/CFRs.

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Ability to evaluate compliance issues.

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Skill in evaluating and documenting according to Company and various guidelines.

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Proficient at maintenance, troubleshooting and operation of equipment in area of expertise.

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Advanced scientific data analysis and interpretation skills.

:Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience (Degree in Chemistry/Biochemistry)

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Fully Bilingual (Spanish and English)