Specialist Quality Control

: Responsible for providing technical guidance. : 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.
Requirements

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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.

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Advanced skills in solving complex problems.

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Advanced data trending and evaluation.

:Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience (BS/MS Chemistry, biology or microbiology)

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Hands on experience in industrial laboratory.

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Experience in HPLC, TOC, ELISA , Capillary Electrophoresis.

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Excellent technical writing skills.

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Fully Bilingual (Spanish and English)