Data Reviewer II

Curia; City of Rensselaer (NY); Presencial; USD 73 000 - 93 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Generous benefits

Paid training

Career advancement

Education reimbursement

401K with matching

Learning platform

Resumo da oferta

Curia seeks a Data Reviewer II in Rensselaer, NY to perform rigorous data reviews of analytical outputs from GC, HPLC/UHPLC, IR, DSC, UV-Vis and more. You will verify traceability, calibration status, and compliance with GDP procedures while supporting QA initiatives and client methods.

The role requires a Bachelor’s in natural science or pharmacy and 3–5 years in QC in a GMP/GLP environment, with strong communication and problem-solving skills.

Qualificações

• Bachelor's degree in natural science or pharmacy and 3–5 years in QC or related industry.
• Experience in cGMP or GLP pharmaceutical environments is required.
• Strong data review, accuracy and data integrity focus.

Responsabilidades

• Perform technical review of analytical data from GC, HPLC/ UHPLC, IR, DSC, UV-Vis, and related methods.
• Verify data traceability, logbooks, calibrations, and stock of standards/reagents.
• Ensure cGMP compliance and assist QA initiatives as needed.
• Provide training and escalation of OOS to QC/QA leadership.
• Enter data into stability summaries and prepare data summaries for management.

Conhecimentos

Data review

cGMP

Instrument interpretation

Attention to detail

Written/verbal communication

Formação académica

Bachelor's Degree in Natural Science or Pharmacy

3–5 years QC experience

Experience in GLP/good laboratory practices

Ferramentas

GC

HPLC/UHPLC

IR

DSC

UV-Vis

Karl Fischer

Descrição da oferta de emprego

Job Description

Data Reviewer II in Rensselaer, NY

Build your future at Curia, where our work has the power to save lives

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer

• 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
• And more!

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 escalation 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 Licensures

Required

• 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.

Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.