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QC Data Reviewer

Raleigh Metro Area, NC

Posted: 11/06/2019 Job Type: Scientific Job Number: JN -112019-25937 Region: Raleigh Metro Area

Job Description

Duties:

Perform data review for QC Chemistry testing to support release of raw materials, drug substance, and drug product in a GMP environment. Strong scientific and data review background as to provide technical knowledge and quality comments associated with raw data review and documentation. Strong background in compendial and/or raw material testing.

RESPONSIBILITIES:

Perform timely data review (chromatography and other data) with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation

Reviews testing for accuracy, completeness, cGMP compliance, and neatness of analytical documentation

Must be able to understand and interpret data ((chromatography and other data)

Verify calculations and documented information such as reagent expiry, reagent preparation, instrument calibration, logbook entries, control charts, etc. are present, complete and accurate.

Verify that all analysis performed were as per methodology and/or compendial methods, and were in compliance with GMP requirements.

Assist laboratory with regard to Out-of-Specification investigations.

Perform weekly logbook checks

Monitor LIMs data for items that require data review and manager review.

Review data for trends

Ability to work effectively under pressure to meet deadlines


Skills:

5 years + of pharmaceutical/GMP testing experience coupled with a minimum of 2 years performing data review.

Compendial Testing and/or review of compendial testing

GMP experience is a must

Advanced knowledge of analytical methods and testing and related instrumentation.

Strong attention to detail

Advanced knowledge of GMPs, safety regulations, LIMS, data integrity


Education:

Minimum: BS degree in Chemistry, or other related scientific field

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