QC Data Review Job

QC DATA REVIEW needed for a CONTRACT opportunity with Yoh's client located in HOLLY SPRINGS, NC.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Data review
- cGMP
- Raw materials

WHAT YOU'LL BE DOING:

- Support organization of the QC Chemistry laboratory.
- Plan and assist with required resources for day to day data review of raw data generated in the QC laboratories.
- Strong scientific and data review background as to provide technical knowledge and quality comments associated with raw data review and documentation.
- Perform timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation
- Review executed protocols for accuracy, completeness, cGMP compliance, and neatness of analytical documentation
- Verify calculations and documented information such as reagent expiry, instrument calibration, logbook entries, control charts, etc. are present, complete and accurate.
- Verify that all analysis performed were as per methodology and/or compendia methods, and were in compliance with GMP requirements.
- Assist laboratory with regard to Out-of-Specification investigations, aborted/invalid investigations and Corrective Actions.
- Perform weekly logbook checks if required.
- Monitor LIMs data for items that require data review and manager review.
- Other applicable tasks assigned by the QC manager

WHAT YOU NEED TO BRING TO THE TABLE:

- Minimum BS degree in Chemistry or other similar related scientific field
- Four to seven (4-7) years of pharmaceutical experience coupled with a minimum of two (2) year performing data review.
- Must have data review experience
- Must have raw materials experience
- USP and EP compendia knowledge
- Advanced knowledge of GMPs, safety regulations and data integrity
- Proficiency in MS Word, MS Excel, Powerpoint
- Prior experience with LIMS system
- Knowledge to maneuver and understand instrument programs
- Experience reviewing documentation
- Advanced knowledge of analytical methods and testing and related instrumentation.
- Needs to have worked with USP and EP compendia in the many different aspects of raw materials testing including everything from ID testing, general wet chemistry. heavy metals, arsenic, KF, gravimetric, titrations, optical rotation, density, TLC, limits testing, UV, HPLC, UPLC.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: SCIENTIFIC

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SFSF: LS