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Scientific. Clinical. Software Engineering

Quality Assurance Analyst for QC Data Review

Raleigh Metro Area, NC

Job Type: Scientific Job Number: JN -042020-26757 Region: Raleigh Metro Area

Job Description

RESPONSIBILITIES:

Perform timely review of lab data and documentation (chromatography and other data) with a high focus on data quality and data integrity.

Perform a Quality review of data and documentation generated during testing for accuracy, completeness, cGMP compliance, and compliance with methods and specifications.

Perform review of electronic data audit trails to ensure data integrity. Must be able to access different instrumentation in the lab to perform audit trail review and have a working knowledge of the instrumentation.

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.

Facilitates laboratory data or documentation corrections with analysts to ensure accuracy. Must be collaborative and be able to communicate well.

Assist laboratory with Out-of-Specification investigations and invalid test investigations.

Review data for trends.

Ability to work effectively under pressure to meet deadlines and manage multiple priorities.

Communicate and discuss testing procedures and documentation with analysts.


SKILLS:

8 years + of pharmaceutical/GMP testing experience coupled with a minimum of 3 years performing data review are required.

Strong scientific, quality, and data review background as to provide technical knowledge and quality comments associated with raw data and documentation.

Strong background in Compendial Testing, raw material testing, wet chemical testing, HPLC/UPLC testing, and use of LIMS.

Advanced knowledge in use of instrumental methods of analysis, such as HPLC/UPLC, Karl Fischer, titrators, AA, UV, IC, TOC, and FTIR

Review of data generated during testing for quality, compliance, and data integrity.

GMP experience is a must and understanding of data integrity is a must.

Good communication and interpersonal skills to support working in a team environment, collaboration, and strong attention to detail are a must.

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

Ability to work effectively under pressure to meet deadlines and manage multiple priorities is a must.


EDUCATION:

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

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