Job Description

Job Title: QA Inspector II (IT)

Location: 7 Oser Avenue, Hauppauge, NY (Onsite)

Employment Type: Hourly/Full Time

Job Overview: The QA Inspector (IT) in a pharmaceutical manufacturing environment focused on Dry Powder Inhalers (DPI), you will ensure the integrity, compliance, and performance of IT systems, contributing directly to product quality and regulatory adherence. You will primarily be responsible for validating and verifying the IT systems supporting manufacturing processes, with a particular focus on audit trail review, data integrity, and overall GxP compliance.

Responsibilities

• Perform detailed reviews of the equipment audit trails associated with batches during production. Verify that each modification or action taken within the system (e.g., data entry, process changes, approvals) is appropriately logged, timestamped, and attributed to the correct users.
• Ensure that all changes to batch records are valid and consistent with the intended production process. Investigate any discrepancies or unauthorized actions in the audit trails and escalate as needed.
• Review user activity logs within the batch record systems to ensure compliance with 21 CFR Part 11 requirements, particularly ensuring that electronic signatures, timestamps, and system access are appropriately documented and validated.
• Ensure that all batch records and associated audit trails comply with 21 CFR Part 11 requirements for electronic records and signatures, ensuring that all system actions are secure, traceable, and compliant with regulatory standard.
• Review of the batch records (manufacturing and packaging) to ensure compliance with GMP, regulatory standards, and internal procedures. Ensure that all relevant data (e.g., production parameters, test results, material lot numbers) is captured accurately and completely.
• Oversee the validation of IT systems used in manufacturing processes, ensuring systems are properly qualified (IQ/OQ/PQ) and meet regulatory requirements.
• Identify and investigate discrepancies or anomalies within the audit trail and escalate issues where unauthorized actions, missing records, or other violations are detected.
• Provide necessary documentation and audit trail reports during internal and external audits (e.g., FDA). Ensure that batch records and audit trails are readily accessible and properly formatted for regulatory review.
• Assist in the training of staff on proper documentation practices, focusing on audit trail review.
• Ensure that all reviewed batch records and audit trail documentation are properly stored, maintained, and accessible in compliance with internal and regulatory requirements for record retention.
• Collaborate with cross-functional teams (e.g., IT, production,) to identify opportunities for improving the batch record review process, particularly in relation to audit trail management and data integrity.
• Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOPs.
• Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
• Other duties [additional support] that management may assign from time to time.

Skills

• Excellent attention to detail and ability to review complex batch records and audit trails.
• Strong understanding of 21 CFR Part 11 regulations, GMP, and other regulatory standards for pharmaceutical manufacturing.
• Experience with electronic batch record (EBR, SCADA) systems and other pharmaceutical IT systems.
• Understanding of audit trail principles, data integrity, and electronic signatures in regulated environments.
• Strong communication skills for preparing reports, providing feedback, and interacting with cross-functional teams and auditors.
• Analytical and problem-solving skills to identify potential issues in batch records and audit trails.

Educational Qualification: Bachelor’s degree in Life Sciences, Information Technology, Pharmaceutical Sciences, or a related field.

Work Experience: Minimum of 2-4 years of experience in Quality Assurance or IT Quality Assurance in a regulated pharmaceutical environment.

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