Data Reviewer II

Curia • Town of Guilderland, NY

17h • $72,000 - $89,938 • Onsite

About The Position

The Data Reviewer II is responsible for review and approval of primary analytical data according to cGMP guidelines. The ideal candidate will be responsible for technical data review to ensure accuracy and integrity, overseeing the implementation of new test methods to maintain compliance with cGMP and SOP requirements. The candidate will possess strong communication, problem-solving, and technical skills, with knowledge in analytical instrumentation such as XRPD, PSD, DSC, TGA, UV, FTIR, HPLC, and GC. This position will also support Quality 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 Curia customers.

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.

Requirements

• Bachelor’s Degree in Chemistry or related field and a minimum of three years’ relevant industry experience; OR Master’s degree and one-year relevant experience
• Knowledge in analytical instrumentation such as XRPD, PSD, DSC, TGA, UV, FTIR, HPLC, and GC
• Strong communication, problem-solving, and technical skills
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• Experience working in cGMP or GLP pharmaceutical industry environment

Responsibilities

• Review quality control testing for compliance with internal SOPs and specifications
• 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
• 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 training to new hires as needed. Attend internal and external training on related subjects, cGMP compliance and data integrity, new techniques and procedures
• Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
• Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
• Provide support on Raw Material release and GMP production suite commissioning activities when necessary
• May perform QA cleaning verification and inspection activities when required
• Other duties as assigned.

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: Mid Level