Data Reviewer II

Curia • Rensselaer, NY

1d • $73,000 - $93,000

About The Position

The Quality Control Data Reviewer II supports manufacturing departments and external customers by reviewing and approving primary analytical data in accordance with cGMP guidelines. The laboratory tests raw materials, in-process materials, finished products, and stability samples. The reviewer evaluates analytical data, including HPLC, Karl Fischer, and USP testing, for compliance and completeness against established SOPs, methods, and procedures.

The role uses sound judgment, critical thinking, and cGMP principles to uphold data integrity and quality standards. It also involves collaborating with laboratory personnel, providing guidance to analysts, supervisors, and quality personnel, and supporting QA initiatives when needed.

Requirements

• Bachelor's degree in Natural Science, Pharmacy, or equivalent.
• Minimum of 3–5 years in QC operations or relevant industrial experience.
• Experience working in a cGMP or GLP pharmaceutical industry environment.
• Chemical Hygiene training.
• Working knowledge of analytical instruments including GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl Fischer auto titrator, optical rotation, and dissolution instruments.
• Ability to understand and interpret analytical techniques such as method validation, method transfer, method verification, and stability testing methodologies.
• Excellent verbal and written communication skills, including the ability to present information and respond to questions from managers, clients, customers, and the general public.
• Ability to meet deadlines and work under pressure with limited supervision.
• Strong time management and organizational skills, with 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) and ISO 9001 and 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

• Assist with technical review of data generated from analytical instruments, including GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl Fischer auto titrator, optical rotation, and dissolution instruments.
• Review raw data from compendial testing (such as USP/NF, EP, and JP) and Curia in-house and client methodologies for accuracy, completeness, and integrity.
• Perform electronic data reviews and electronic signatures.
• Verify traceability of samples, standards, reagents, and instruments.
• Verify that usage logbooks, instrument calibration, and shelf life of standards and reagents are current, and that GDP procedures are followed.
• Verify calculations associated with testing against applicable procedures.
• Escalate out-of-specification results identified during data review to QC and QA leadership.
• Verify chromatography data does not include trial injections.
• Promptly ensure corrections identified during data review are 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, and compile data summaries for management.
• Ensure testing complies with cGMP and company standard operating procedures.
• Support QA initiatives, including investigations and change controls, when necessary.
• Review testing data received from external laboratories according to site procedures.
• Ensure manual chromatography integrations are appropriately authorized by QC leadership.
• Train new hires as needed and attend internal and external training related to cGMP compliance, data integrity, techniques, and procedures.
• Perform other related duties as reasonably assigned.

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: Mid Level