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- Franklin Township, NJ 08873
- Arra Lam
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QC Data Reviewer- 2nd shift- Somerset, NJ 08873
Kelly Scientific Resources • Franklin Township, NJ
Posted 7 days ago
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QC Data Reviewer 2nd shift- 3pm-11pm
Somerset New Jersey- 08873- Contract to hire
The primary responsibility of the data reviewer is to ensure all data and documentation, including source data and summary reports from the laboratory, are of the highest quality, ensuring data accuracy and integrity. The data reviewer reviews all Chemistry data (source data and summary reports) for accuracy, conformance to procedures and specifications, and proper documentation in accordance with SOPs and cGMPs. The assigned individual also reviews raw data, for use of appropriate Chemistry instrumentation use, accuracy of calculations and conformance to all referenced Chemistry procedures and reviews the interpretation of the data for alignment with method validation reports and scientific legitimacy. The data reviewer reviews all electronic data audit trails in detail to ensure data integrity is not compromised in any way and ensures all signatures, electronic or written are intact prior to the release of laboratory data. The reviewer is responsible for discussing data interpretation and questions with individual analysts and elevate to Management, if necessary, to determine data disposition.
- Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory
- Reviews all source data and associated documentation for accuracy and cGMP conformance.
- Reviews all source data for conformance to applicable specifications
- Facilitates data or documentation corrections with analysts to ensure all records are complete and appropriate references are made.
- Ensures investigations are assigned, completed and referenced for data or documentation, as appropriate, prior to release of Chemistry data
- Responsible for verifying all laboratory testing was conducted in accordance with SOPs as well as cGMPs
- Review of laboratory notebooks and other source data (e.g. printouts, logbooks, executed forms, etc.) for completeness, and archival, as appropriate.
- Interacts closely with Quality Management and all team members to identify and aid in the implementation of data security, integrity or efficiency improvements
- Interacts routinely with departments such as Production, QA, RA, R&D, Validation
- Works on multiple projects in a concurrent manner on a routine basis.
- Assist in performing Quality Assurance audits on laboratory areas to ensure cGMP compliance
- Assist in the investigation and review of deviation reports and OOS reports to assure complete and compliant source data.
- Assist in training and mentoring junior analysts on the interpretation of data and use of electronic data systems.
EDUCATION AND EXPERIENCE:
Must have a minimum of a Bachelor's degree (BS) in Chemistry with at least three (3) years of experience in an industrial laboratory related to pharmaceutical manufacturing, specializing in sterile dosage forms.
Must have complete knowledge of pharmaceutical chemistry testing and the ability to clearly interpret department procedures, current Good Manufacturing Practices, United States Pharmacopeia, Code of Federal Regulations (CFR) and other applicable FDA regulations or guidelines.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.