Batch Record Reviewer

Apply

Description

Position Summary:

• Responsible for reviewing finished product for overall completeness and correctness per cGMP in the batch records.

• Responsible for reviewing and verifying batch records prior to scanning.

• Assists with additional work duties or responsibilities as evident or required.

• Performs other duties as assigned or apparent.

• Review the batch records for cGMP compliance, SOP deviations, and completeness.

• Verify that all data, signatures, and dates have been entered.

• Verify all equipment is within its calibration period.

• Verify all preventative maintenance was performed.

• Ensures scans are complete and an accurate reproduction of the documents.

• Communicates with the appropriate department any issues identified during scanning or verification of scanned documents.

• Ensures the general upkeep of documents before and after scanning.

• Assists in ensuring that all scanned documentation is returned to the designated department.

• Monitors the scanning processes to safeguard data integrity and proper document retention.

• Assist with issuing and approving batch records when needed.

• Verify prepared Batch Records before sending batch records to production floors when necessary.

• Perform general tasks such as archiving, retaining records, approval/release of Certificates of Analysis, use of special test request and report forms, etc.

Requirements

Knowledge, Skills & Abilities

• High School Diploma is required; 2 year Associate of Art Degree is preferred.

• Experience working in a Pharmaceutical environment as Quality Assurance is preferred.

• Computer knowledge, people skills, good communication, strong GMP background.

• Specific expertise, skills and knowledge within batch record reviewing gained through education and experience.

• Attention to detail is important

• The ability and willingness to change direction and focus to meet shifting organizational and business demands.

• The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides feedback and recognition.

• The ability to demonstrate integrity, effectively manage oneself, be productive under pressure, and achieve personal and department goals.

• The ability to manage a multitude of resources and to be accurate and current with data and information.

• Salary range: Based on experience.