Pamela Egan

Works with foreign and domestic clients in the pharmaceutical, medical device and biotechnology industries to develop quality assurance and regulatory strategies for compliance with regulations. Perform Batch Record Review and Batch Release.

Induced mutations in mammalian cells using x-rays and various mutagenic chemicals. Maintained all cell lines for use in experimentation and performed DNA sequencing.

Performed human monoclonal antibody EIA assays to determine the ideal component configuration for efficacy and specificity for the second-generation HCV diagnostic test. This role contributed to the development of advanced diagnostic solutions.

Performed EIA/RIA HBsAg assays to test raw material, in-process, finished product, and stability testing while following cGMP, USP, SOP, ISO, FDA, and OSHA regulations. Performed cGMP audits.

Supervised floor operations for all HBsAg product testing and documentation. Scheduled and coordinated incoming raw material, in-process, finished product, and stability testing materials for testing for first and second shift.

Revamped the entire training program for the Technical Support Specialist position. Addressed technical customer complaints for all EIA/RIA monoclonal antibody products and instrumentation.

Manufactured and scaled-up monoclonal antibodies for all diagnostic products. Managed hollow fiber bioreactor production runs, ensuring efficient and compliant operations.

Supervised the manufacturing and scale-up of antibodies for use in bioreactor production. This role was critical in advancing biotechnological product development and production.

Managed Teaching Assistants for Chemistry, Biology, and Physics labs. Implemented and maintained a new inventory system for all chemicals, glassware, instruments, and general laboratory supplies.

Reviewed cell culture and purification batch records to assure compliance requirements. Reviewed supporting documentation including equipment logbooks, cleaning logs, environmental monitoring data, sterilization cycles, and quality control results.

Provided compliance support for the new insulin manufacturing site. Reviewed user requirements, system classifications, and technical specifications for both the Isolated Cartridge Filling Line and the Automated and Semi-Automated Visual Inspection Machines to ensure that quality requirements were met.

Prepared CMC regulatory submissions and implemented Common Technical Documents. Provided regulatory reviews of documents required for regulatory submissions.

Directed the requirements of the quality system and created and presented all required employee training. Participated in the formation of a new company that helps subsidize patient financial hardships.

Supervised batch record review and led a team that successfully reviewed and closed 4000 batch records in 6 months. Restructured the batch record review process that led to timely review and compiled monthly and quarterly batch record review metrics.

Hosted all customer audits and developed training programs for the Quality Assurance department. Trained employees on the TrackWise process for quality review, complaint, and return modules.

Wrote, reviewed, and approved deviations and managed the CAPA system. Successfully implemented a new procedure that resulted in timely closure and provided support to Quality Assurance Batch Record Review.

Led an Investigation Consulting Team which resulted in the closure of 100 high priority deviations in six weeks, exceeding client expectations. Led a consulting Batch Record Review Team which resulted in improving the compliance of client batch records.

Led a Consulting Change Control Team which resulted in streamlining the process, updating procedures, and improving timely closure. Performed third-party coaching, mentoring, and oversight of change controls to ensure effective changes.

Reviewed Customer Complaints for injectable products. This role focused on ensuring proper documentation and resolution of customer feedback related to sterile/aseptic/vaccine manufacturing.

Provided Quality support to ensure adherence to regulatory requirements and internal procedures. Performed Batch Record Review, contributing to the compliance and quality assurance of injectable products.

Performed microbiological investigations for injectable products. This role involved detailed analysis and problem-solving to address quality issues related to sterile/aseptic/vaccine manufacturing.

Provided general and strategic consultation to prepare for an upcoming PAI inspection. Led a team of consultants to update and create needed Quality System SOPs, specifically creating Deviation, Complaint, and Change Control SOPs.

Developed and implemented an entire Quality Management System (QMS) and converted a paper-based Quality System to an electronic Trackwise Quality System. Implemented a Remediation Plan in response to a prior FDA Warning Letter and 483 observations, providing FDA with monthly remediation updates.

Reviewed batch records retrospectively per FDA response commitment for injectable products. This role ensured compliance with regulatory requirements and supported the client's post-audit remediation efforts.

Supported Quality and Manufacturing for the commercialization of a new drug product and participated in a successful FDA audit that led to final approval. Reviewed batch records in real time and provided general and strategic consultation to prepare for upcoming PAI.

Developed and implemented a Quality Customer Complaint System for injectable products. This initiative streamlined the complaint handling process and improved regulatory compliance.

Reviewed Lab Data for Data Integrity Issues, focusing on injectable products. This role was crucial in ensuring the reliability and compliance of laboratory data within the sterile/aseptic/vaccine sector.

Created Quality System SOPs for a start-up biotechnology company and reviewed Master Batch Records. Coached and mentored on investigation writing, root cause analysis, CAPA, and effectiveness checks.

Performed batch record review and improved quality systems for injectable products. This role focused on enhancing compliance and efficiency within the sterile/aseptic/vaccine manufacturing environment.

Led the manufacturing quality group and performed batch record review, including packaging records. Reviewed deviation reports, including root cause analysis, and performed product release, including completing the Certificate of Release and associated documents in Veeva.

Performed batch record review, including packaging records, and product release, including completing the Certificate of Release and associated documents in Veeva. Reviewed deviation reports, including root cause analysis, and collaborated with pharmaceutical development, supply operations and CMO external global partners, including the EU QP, to ensure adequate oversight of manufacturing and supp

Completed a Bachelor of Science degree with a focus on Biology. The curriculum provided a strong foundation in biological sciences.