Job DescriptionData Reviewer II in Rensselaer, NY
The Quality Control Data Reviewer II 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. 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Essential Duties and Responsibilities- Assist in technical review of 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.
- The review entails a 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, completeness and 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
- Verify calculations associated with testing are correctly done per procedures
- Responsible to 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 the corrections identified from the data review are addressed per approved procedures
- 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
- 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 the 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
- Perform other related duties as may be reasonably assigned in the course of business
Education, experience, certification and licensuresRequired- Bachelor's Degree in Natural Science, Pharmacy or equivalent
- Minimum 3-5 years' in QC operations or relevant industrial experience
- Experience working in cGMP or GLP pharmaceutical industry environment
Preferred- Experience in commercial QC laboratories
Knowledge, skills and abilities- 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), 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
Other Qualifications
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
Pay Range: $73,000 - $93,000
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
