Coordination of analytical development work packages that were outsourced to external and internal service providers. Specialized with Raw Materials department to outsource excipients and other raw materials for Release testing and/or Risk Assessments. Worked in partnership with multiple teams to establish contracts and purchase orders by request and assessment of quotes for services. Planning and monitoring of outsourced activities within the given project timeline in close collaboration with the internal project team and the service provider. Responsible for GMP document transfer for all documentation to Third Party Laboratories. Authoring and archiving of documents in a GMP environment. Verification of analytical data from service providers.

Coordinated compliance management of new staff members by supervising, planning, organizing, and delegating lab staff’s daily activities.Recruited, interviewed, and instructed 20+ new staff members under compliance guidelines.Supervised daily meetings with staff to ensure all assignments were completed.Expedited human cadaveric specimen delivery to company’s clients. Received, processed, procured, and sent out human cadaveric specimen domestically and internationally, based on client specifications. Ensured compliance with FDA regulations by following all guidelines to ensure specimen arrived on time with proper documentation for traceability and recovery.

Quality Compliance specialist brought in to fulfill regulations for FDA Consent Decree.Developed company work plans, including As-Is and To-Be process mapping, Deliverable Concurrence, and other critical projects to ensure compliance with FDA Consent Decree.Collaborated with a team of five to create, execute, and transmit work plans overseas to comply with company regulations for the FDA Consent Decree.

Extensive experience with BioPharm stability practices and data management. Maintained operation of stability program including the acquisition and delivery of stability samples to testing labs according to daily pull schedules. Maintenance of stability chambers including daily temperature monitoring and routine maintenance for calibration and validation. Reviewed and approved data from release and stability testing of formulations to support pre-clinical and clinical packaging studies. Created and issued multiple regulatory reports and stability submissions for Regulatory filings. Responsible for developing compliant stability strategies, authoring stability protocols, ensuring execution of stability studies and the critical evaluation and reporting of stability data including assigning expiration dates and trending. Proficient experience with statistical trending analytical experience. Strong working knowledge in a biopharmaceutical quality control and/or development laboratory environment with experience in associated analytical methods (SDS-PAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay). Performed periodic reviews to update and release numerous analytical testing methods. Drug Product, Drug Substance, Reference Standard, and Placebo specification review and release. Initiated and executed various Change Controls in accordance with compliance regulations. Trained in Audit Preparation for Level 1, 2, and 3 audits. Preparation and maintenance of scheduling for stability pulls.

Perform a variety of routine and non-routine tasks in compliance with cGMPs. Maintained operation of stability program including the acquisition of stability samples according to daily pull schedules. Requisition of stability samples, sample storage within stability chambers, authoring of protocols, distribution of samples to testing labs, approved lab data, writing / reviewing stability reports, issued multiple reports along with writing stability submissions. Responsible for developing compliant stability strategies, authoring stability protocols, ensuring execution of stability studies and the critical evaluation and reporting of stability data including assigning expiration dates and trending.

Recovery and analysis for microbial content associated with sterile products. Recovery includes isolation, growth, and identification of bacteria, yeasts, and molds within FDA regulations, cGMP and cGLP guidelines. Performed testing on raw materials used for pharmaceutical production. Maintain and document data by trending, identifying short-term and long-term trends. Proficient in Microsoft Word, Excel, and PowerPoint.