Data Reviewer I (QC)

Curia • Town of Guilderland, NY

5d • Onsite

About The Position

The Quality Control Data Reviewer I is responsible for supporting the Stability & Reference Standard department and external customers. The principal responsibility of this role is the review and approval of primary analytical data according to cGMP guidelines. The QC Data Reviewer will be expected to review analytical data including HPLC, KF, USP testing for compliance and completeness against established SOPs, methods and procedures. This 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.

Requirements

• Bachelor’s Degree in Chemistry or a related field
• Chemical Hygiene training
• 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.
• Understand and interpret complex analytical techniques such as Method Validation, Method Transfer, Method Verification, Stability testing methodologies
• Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of 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 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
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• One year experience working in cGMP or GLP pharmaceutical industry environment

Responsibilities

• Utilize 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.
• 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
• 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
• 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
• Review and approve test methods, SOPs, forms, and other documents as necessary
• Interact with outside departments including attending meetings, providing updates, etc.
• Coordinate testing performed at contract testing labs for stability samples etc.
• Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures

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: Entry Level