Data Reviewer III

Curia • City of Rensselaer, NY

5h • $84,000 - $104,800 • Onsite

About The Position

The Quality Control Data Reviewer III supports manufacturing departments and external customers in a laboratory that tests raw materials, in-process materials, end products, and stability samples. The principal responsibility is reviewing and approving primary analytical data in accordance with cGMP guidelines. The reviewer evaluates analytical data, including HPLC, Karl Fischer, and USP testing, for compliance and completeness against established SOPs, methods, and procedures. The role also supports QA initiatives when needed and collaborates with laboratory personnel to review data for cGMP compliance and data integrity. It requires sound judgment and critical thinking to ensure data meets acceptable quality standards, and includes providing guidance to analysts, supervisors, and quality personnel.

The position reviews analytical data from a range of instruments and compendial, in-house, and client methods; verifies traceability, calculations, instrument calibration, and the currency of standards and reagents; and carries out electronic reviews and signatures. The reviewer also works with stability tables and protocols, tracks and trends data as requested, escalates identified out-of-specification results, and supports training and QA activities. This is an onsite position in Rensselaer, New York.

Requirements

• Bachelor's degree in Natural Science, Pharmacy, or equivalent.
• Five to eight years of experience in QC operations or relevant industrial experience.
• Experience working in a cGMP or GLP pharmaceutical industry environment.
• Chemical Hygiene training.
• Working knowledge of analytical instrumentation, including GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl Fischer auto titrator, optical rotation, and dissolution instruments.
• Ability to understand and interpret complex analytical techniques, including method validation, method transfer, method verification, and stability testing methodologies.
• Excellent verbal and written communication skills, including ability to present information effectively and respond to questions from managers, clients, customers, and the public.
• Ability to meet deadlines and work under pressure with limited supervision.
• Strong time management and organizational skills, including the ability to multitask and manage multiple projects independently.
• Ability to apply mathematical concepts, operations, and tasks.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Proficiency in Microsoft Office Suite and instrument manufacturer-based systems.
• Knowledge of FDA GMPs (21 CFR, 211, 820, and/or 600), ISO 9001, and ISO 13485.
• Must pass a background check and drug screen; may be required to pass Occupational Health Screening.

Nice To Haves

• Experience in commercial QC laboratories.

Responsibilities

• Review raw data from analytical instruments, including GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl Fischer auto titrator, optical rotation, and dissolution instruments.
• Technically review raw data for compendial testing and Curia in-house and client methods to ensure accuracy, completeness, and data integrity.
• Perform electronic data reviews and signatures.
• Verify traceability of samples, standards, reagents, and instruments.
• Verify instrument usage logs and calibration, confirm standards and reagents are within shelf life, and ensure GDP procedures are followed.
• Verify that testing calculations are correct and follow procedures.
• Escalate out-of-specification results identified during data review to QC and QA leadership.
• Verify that chromatography does not contain trial injections and that manual integrations are appropriately authorized by QC leadership.
• Ensure corrections identified during data review are promptly addressed according to approved procedures.
• Format and review stability summary tables and stability protocols for accuracy and compliance with current Curia formats.
• Enter data into stability summary tables; track and trend data as requested; compile data and provide summaries to management.
• Ensure tests comply with cGMP and company SOPs.
• Support QA initiatives, including investigations and change controls, when needed.
• Review testing data received from external laboratories according to site procedures.
• Provide training to new hires as needed and attend internal and external training on related subjects, cGMP compliance, data integrity, and new techniques and procedures.
• Perform other related duties reasonably assigned in the course of business.

Benefits

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

What This Job Offers

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