Batch Record Reviewer
Position
Summary:
Responsible for reviewing finished product for overall completeness and correctness per cGMP in the batch recordsResponsible for reviewing and verifying batch records prior to scanningAssists with additional work duties or responsibilities as evident or requiredPerforms other duties as assigned or apparentReview the batch records for cGMP compliance, SOP deviations, and completenessVerify that all data, signatures, and dates have been enteredVerify all equipment is within its calibration periodVerify all preventative maintenance was performedEnsures scans are complete and an accurate reproduction of the documentsCommunicates with the appropriate department any issues identified during scanning or verification of scanned documentsEnsures the general upkeep of documents before and after scanningAssists in ensuring that all scanned documentation is returned to the designated departmentMonitors the scanning processes to safeguard data integrity and proper document retentionAssist with issuing and approving batch records when neededVerify prepared Batch Records before sending batch records to production floors when necessaryPerform general tasks such as archiving, retaining records, approval/release of Certificates of Analysis, use of special test request and report forms, etcRequirements Knowledge, Skills & Abilities High School Diploma is required; 2 year Associate of Art Degree is preferredExperience working in a Pharmaceutical environment as Quality Assurance is preferredComputer knowledge, people skills, good communication, strong GMP backgroundSpecific expertise, skills and knowledge within batch record reviewing gained through education and experienceAttention to detail is important The ability and willingness to change direction and focus to meet shifting organizational and business demandsThe ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides feedback and recognitionThe ability to demonstrate integrity, effectively manage oneself, be productive under pressure, and achieve personal and department goalsThe ability to manage a multitude of resources and to be accurate and current with data and informationSalary range:
Based on experience.
Recommended Skills Managed Care Utilization Management Healthcare Effectiveness Data And Information Set Medicare Medical Management Credentialing Estimated Salary: $20 to $28 per hour based on qualifications.
Summary:
Responsible for reviewing finished product for overall completeness and correctness per cGMP in the batch recordsResponsible for reviewing and verifying batch records prior to scanningAssists with additional work duties or responsibilities as evident or requiredPerforms other duties as assigned or apparentReview the batch records for cGMP compliance, SOP deviations, and completenessVerify that all data, signatures, and dates have been enteredVerify all equipment is within its calibration periodVerify all preventative maintenance was performedEnsures scans are complete and an accurate reproduction of the documentsCommunicates with the appropriate department any issues identified during scanning or verification of scanned documentsEnsures the general upkeep of documents before and after scanningAssists in ensuring that all scanned documentation is returned to the designated departmentMonitors the scanning processes to safeguard data integrity and proper document retentionAssist with issuing and approving batch records when neededVerify prepared Batch Records before sending batch records to production floors when necessaryPerform general tasks such as archiving, retaining records, approval/release of Certificates of Analysis, use of special test request and report forms, etcRequirements Knowledge, Skills & Abilities High School Diploma is required; 2 year Associate of Art Degree is preferredExperience working in a Pharmaceutical environment as Quality Assurance is preferredComputer knowledge, people skills, good communication, strong GMP backgroundSpecific expertise, skills and knowledge within batch record reviewing gained through education and experienceAttention to detail is important The ability and willingness to change direction and focus to meet shifting organizational and business demandsThe ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides feedback and recognitionThe ability to demonstrate integrity, effectively manage oneself, be productive under pressure, and achieve personal and department goalsThe ability to manage a multitude of resources and to be accurate and current with data and informationSalary range:
Based on experience.
Recommended Skills Managed Care Utilization Management Healthcare Effectiveness Data And Information Set Medicare Medical Management Credentialing Estimated Salary: $20 to $28 per hour based on qualifications.
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