Quality Assurance Consultant

Quality Assurance Consultant

Location: Remote (Long Island, NY)

Duration: 12 Month

JOB DESCRIPTION

Quality Assurance (QA) role, 21 CFR Part 11 expertise is a high-value skill for ensuring that electronic records and signatures are as trustworthy as their paper counterparts. This compliance is mandatory for FDA-regulated sectors like pharmaceuticals, medical devices, and clinical research. 

Key Responsibilities & Skills

• Computer System Validation (CSV): QA professionals oversee the validation lifecycle—from User Requirement Specifications (URS) to IQ/OQ/PQ—to prove that systems consistently perform as intended.
• Audit Trail Oversight: You must ensure systems generate secure, time-stamped audit trails that track who created, modified, or deleted data and why.
• Access & Security Control: QA verifies that unique user IDs and strong passwords are used and that "shared accounts" are strictly prohibited.
• Electronic Signature Management: You must ensure e-signatures are uniquely linked to an individual and include the signer’s name, date/time, and the "meaning" of the signature (e.g., approval, review).
• SOP Development: Draft and maintain Standard Operating Procedures (SOPs) for data retention, system backup, and disaster recovery to meet FDA expectations.