Job Description

Data Reviewer II in Albany, NY

The Data Reviewer II is responsible for review and approval of primary analytical data according to cGMP guidelines. The ideal candidate will be responsible for technical data review to ensure accuracy and integrity, overseeing the implementation of new test methods to maintain compliance with cGMP and SOP requirements. The candidate will possess strong communication, problem-solving, and technical skills, with knowledge in analytical instrumentation such as XRPD, PSD, DSC, TGA, UV, FTIR, HPLC, and GC. This position will also support Quality initiatives when necessary and collaborate with laboratory personnel to review data per cGMP compliance and data integrity. The Reviewer should incorporate sound judgement, critical thinking, and cGMP principles to ensure the integrity of the data meet acceptable quality standards. In addition, the Reviewer will provide appropriate guidance to analysts, supervisors, and quality personnel to promote compliance for Curia customers.

Responsibilities

• Review quality control testing for compliance with internal SOPs and specifications
• Assist in technical data review of the raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia In-house and client methodologies for various client projects to ensure data accuracy and integrity
• Collaborate with lab personnel for data review per cGMP compliance, data integrity
• Ensure all tests are per cGMP compliance and in compliance with the company's standard operating procedures
• Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
• Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
• Provide support on Raw Material release and GMP production suite commissioning activities when necessary
• May perform QA cleaning verification and inspection activities when required
• Other duties as assigned.

Qualifications

• Bachelor's Degree in Chemistry or related field and a minimum of three years' relevant industry experience; OR
• Master's degree and one-year relevant experience

Preferred

• Experience working in cGMP or GLP pharmaceutical industry environment

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay Range: $72,000-$89,938/yr.

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.

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