Data Reviewer III

Curia • Town of Guilderland, NY

17h • $84,000 - $104,824 • Onsite

About The Position

The Data Reviewer III is responsible for supporting the manufacturing department, Stability & Reference Standard department, and external customers. The principal responsibility of the Data Reviewer III is the review and approval of primary analytical data according to cGMP guidelines. The Data Reviewer will be expected to review analytical data including XRPD, PSD, DSC, TGA, UV, FTIR, HPLC, KF, USP testing for compliance and completeness against established SOPs, methods and procedures. The position will also support QA 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 our customers. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Requirements

• Bachelor’s Degree in Chemistry or related field and a minimum of five years’ relevant industry experience; OR Master’s degree and three years’ relevant experience
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience working in cGMP or GLP pharmaceutical industry environment

Responsibilities

• Responsible for 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
• Must have working knowledge and understanding of various analytical instrumentation including but not limited to Gas Chromatography (GC), High-performance liquid chromatography (HPLC/UHPLC), ICP-MS, Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
• Trend stability data to ensure consistency with historical timepoints and no unexpected results
• Verify calculations associated with Stability samples/Reference standards/Raw Materials/Intermediates testing are correctly done
• Format and review Stability summary tables, Stability Protocols for accuracy and compliance with current Curia formats
• Enter data into Stability summary tables. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
• Collaborate with lab personnel for data review per cGMP compliance, data integrity
• Perform electronic review and signatures while reviewing electronic data
• Verify for traceability of samples, standards, reagents, instruments etc.
• Verify the usage logbook, calibration of instruments and shelf life of standards and reagents used are current and GDP procedures are followed
• Ensure the testing data received from external labs are reviewed per site procedures
• Make sure all tests are per cGMP compliance and in compliance with the company’s standard operating procedures
• Provide support on QA initiatives (Investigations, change controls etc.) when necessary
• Review and approve test methods, SOPs, forms, and other documents as necessary
• Support supervisors in OOS Investigations and complete CAPA requirements
• Participate in customer technical discussions for analytical issues
• Interact with outside departments including attending meetings, providing updates, etc.
• Coordinate testing performed at contract testing labs for stability samples etc.
• Provide training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
• Provide guidance to lower level Data Reviewers as needed

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level