Data Reviewer III
Curia
Summary
The Quality Control Data Reviewer III is an integral part of the Curia team and is responsible for supporting manufacturing department and external customers. The routine functions of the laboratory are testing of raw materials, in-process, end product, and stability samples. The principal responsibility of this role is the review and approval of primary analytical data according to cGMP guidelines.
Job description
Essential Duties and Responsibilities
- Review data generated from various analytical instrumentation including but not limited to Gas Chromatography (GC), high-performance liquid chromatography (HPLC/UHPLC), Infrared spectroscopy (IR), Differential scanning calorimeter (DSC), UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
- Perform technical data review of raw data generated for various compendial testing (such as USP/NF, EP, JP, etc.) as well as Curia in-house and client methodologies to ensure data accuracy, completeness and integrity
- Perform electronic review and signatures while reviewing electronic data
- Verify traceability of samples, standards, reagents, instruments etc.
- Verify usage logbook, calibration of instruments and shelf life of standards and reagents used are current and GDP procedures are followed
- Verify calculations associated with testing are correctly done per procedures
- Escalate OOS's identified in data review to the QC and QA leadership
- Verify chromatography associated with the testing does not include any trial injections
- Promptly ensure corrections identified from the data review are addressed per 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; perform tracking and trending of data as requested; compile data and provide data summaries to management
- Ensure 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
- Ensure testing data received from external labs are reviewed per site procedures
- Ensure any manual integrations in chromatography is appropriately authorized by QC leadership
- Provide training to new hires as needed
- Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
Knowledge, Skills and Abilities
- Working knowledge and understanding of various analytical instrumentation including GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl-Fischer auto titrator, Optical rotation, Dissolution, etc.
- Understand and interpret complex analytical techniques such as Method Validation, Method Transfer, Method Verification, Stability testing methodologies
- Excellent verbal and written communication skills
- Ability to meet deadlines and work under pressure with limited supervision
- Strong time management and organizational skills with the ability to multi-task 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
- Proficient in Microsoft Office Suite and instrument manufacture-based systems
- Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
Requirements
- Bachelor's Degree in Natural Science, Pharmacy or equivalent
- Minimum 5-8 years' in QC operations or relevant industrial experience
- Experience working in cGMP or GLP pharmaceutical industry environment
- Working knowledge of analytical instrumentation including GC, HPLC/UHPLC, IR, DSC, UV-Vis, Karl-Fischer, Optical rotation, Dissolution
- Understanding of Method Validation, Method Transfer, Method Verification, Stability testing methodologies
- Excellent verbal and written communication skills
- Strong time management and organizational skills
- Proficient in Microsoft Office Suite and instrument manufacture-based systems
- Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485
- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Benefits
- Generous benefit options
- Paid training
- Paid vacation
- Paid holidays
- Career advancement opportunities
- Education reimbursement
- 401(k) Matching
- Learning platform
Company overview
Curia is a leading global Contract Development and Manufacturing Organization (CDMO) with over 30 years of experience in the pharmaceutical industry. Headquartered in Albany, New York, the company operates an integrated network of 25 global sites across North America, Europe, and Asia, employing approximately 3,500 professionals. Curia provides comprehensive end-to-end solutions spanning drug discovery, development, and manufacturing services for both small molecules and biologics. Their expertise covers active pharmaceutical ingredient (API) manufacturing, sterile drug product development, analytical testing, and regulatory support. The company specializes in complex areas including high-potency compounds, controlled substances, sterile APIs, and mRNA manufacturing. With state-of-the-art GMP facilities and a strong focus on innovation, Curia partners with pharmaceutical and biotechnology companies to accelerate the development and commercialization of life-changing therapeutics, from early-stage discovery through commercial-scale production.