Charles Avila

• Led a QA floor support team, ensuring full compliance with Minaris policies and standards.
• Supervised and coordinated the daily activities of QA staff to maintain efficient workflow and timely task completion.
• Facilitated training sessions on quality assurance requirements and processes.
• Provided technical expertise in tech transfer activities.
• Managed the Batch Issuance and Batch Record Tracking System.
• Reviewed and approved SOPs, Work Instructions, and Forms; initiated and oversaw critical change control processes.
• Assisted in gathering information and supporting audits, including cGMP, client, and regulatory agency audits.
• Supported continuous improvement initiatives and coordinated job rotation and cross-training programs.
• Made informed decisions within established practices and policies; confidently handled non-routine issues.
• Conducted supervisory responsibilities, including hiring, training, and performance evaluations.
• Boosted customer satisfaction by promptly addressing concerns, investigating root causes, and implementing corrective actions.
• Promoted a safety-first mindset among team members, contributing to a decrease in workplace accidents.
• Ensured timely resolution of customer complaints related to product quality through thorough investigation and root cause analysis techniques.

Additional Responsibilities:

• Conducted raw material inspections.
• Reviewed and disposed of batch records.
• Ensured adherence to aseptic behavior standards in a clean room environment.
• Conducted internal audits to maintain compliance and quality standards.

• Led and managed Quality Assurance Shop Floor (QASF) operations in alignment with Bristol Myers Squibb's quality standards, regulatory requirements, and industry best practices.
• Ensured strict adherence to study protocols, standard operating procedures (SOPs), and applicable regulations within QASF.
• Oversaw data management, including the compilation, calculation, and statistical analysis of test results to ensure accuracy and compliance.
• Collaborated with cross-functional teams to draft study summaries and comprehensive final reports for submission to sponsors.
• Maintained research study files in full compliance with FDA and GCP regulations for IND studies.
• Facilitated the submission of research protocols, safety information, and regulatory documents for IRB approval.
• Interacted with clients to maintain strong relationships and provide necessary support for existing accounts.

• Carried out specific departmental responsibilities as assigned by the Director of Photobiology.
• Ensured the accurate, consistent, and compliant review of Photobiology study data, documents, records, and folders.
• Reviewed and integrated standard operating procedures, protocols, and regulatory requirements into laboratory operations.
• Managed data compilation, test result calculations, and conducted statistical analyses to support study objectives.
• Authored study summaries and final reports for submission to sponsors.
• Created and maintained research study files in compliance with FDA and GCP regulations.
• Facilitated the submission of research protocols and safety information for IRB approval.
• Assisted the Director in maintaining and supporting existing client accounts.
• Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.

• Planned and oversaw the daily activities of QA Department Auditors, ensuring alignment with operational priorities and the CPTC Quality Management System.
• Ensured the timely review of CPTC study data, documents, records, and reports for accuracy, completeness, and compliance with quality management system requirements, study protocols, and regulations.
• Monitored and audited laboratory operations and procedures to ensure ongoing compliance with quality management system requirements and regulatory standards.
• Acted as key point of contact for all QA aspects of releases by providing QA services and coordinating QA resources internally and externally.

• Reviewed CPTC study data, documents, records, and reports to ensure accuracy, consistency, completeness, and compliance with quality system requirements, study protocols, and regulations.
• Conducted periodic monitoring and audits of laboratory operations and procedures to uphold quality standards.
• Participated in the execution of CPTC Quality System programs and ensured adherence to requirements.
• Assisted QA Department Group Leaders with special projects and tasks.
• Supported the maintenance and organization of CPTC archive facilities.

• Reviewed batch records and authorized product releases to the market.
• Authorized and revised Standard Operating Procedures (SOPs) to maintain up-to-date practices.
• Performed defect classification on finished products to ensure compliance with quality criteria.
• Coordinated with laboratories and external partners for raw material and final product testing and shipping.
• Maintained Quality Assurance Good Manufacturing Practice (GMP) documentation and managed retention samples.
• Created Certificates of Analysis for both bulk and packaged products.
• Initiated and managed special projects within LACES/LIMS.
• Supported monthly and quarterly testing commitments to meet regulatory and operational requirements.
• Assisted in internal and external audits to ensure compliance with standards and regulations.