Data Integrity Reviewer, Pre-Submission QA

SUN PHARMA; Town of Brunswick (NY); On-site; USD 60,000 - 75,000; Full time

Job summary

A leading pharmaceutical company in New York is seeking a Data Reviewer for the Office of Data Reliability. This entry-level position involves critical review of pre-submission applications ensuring data integrity, reliability, and compliance with regulatory standards. Candidates should possess at least a B.S. in a relevant scientific field and 5 years of experience in a cGMP environment. Proficiency in MS Office and strong communication skills are essential. This role offers a full-time employment opportunity within a corporate office environment.

Qualifications

• Minimum 5 years in a pharmaceutical company within a cGMP environment.
• Proficient in MS Office for audits and documentation.
• Knowledge of cGMP/cGLP requirements and FDA guidelines.

Responsibilities

• Review pre-submission applications for regulatory compliance.
• Ensure data integrity and audit documentation accurately.
• Communicate audit findings to stakeholders as needed.

Skills

Knowledge of laboratory test procedures

Ability to monitor and prioritize work

Excellent interpersonal communication

Proficient in MS Office applications

Education

Bachelor of Science (B.S.) in Chemistry, Pharmacy, or related field

Master of Science (M.S.) in Chemistry, Pharmacy, or related field

Job description

A leading pharmaceutical company in New York is seeking a Data Reviewer for the Office of Data Reliability. This entry-level position involves critical review of pre-submission applications ensuring data integrity, reliability, and compliance with regulatory standards. Candidates should possess at least a B.S. in a relevant scientific field and 5 years of experience in a cGMP environment. Proficiency in MS Office and strong communication skills are essential. This role offers a full-time employment opportunity within a corporate office environment.