- Manage and lead Asana usage for project team- Lead and manage commercialization process for new product development for key accounts from conception to production across multiple sites- Identify and mitigate issues that pose risks to project plans- Facilitate internal meetings between cross functional teams to ensure all deliverables for a project are met- Ensure project completion in accordance to timeline and customer specifications

- Assists with general patient care following established clinic workflows- Greets and prepares patients for the health care provider by completing intake duties such as documenting the patient’s reason for visit, obtaining and recording vital signs, reviewing documented drug allergies, asking if patient taking medications listed in EMR, and completing appropriate screening questionnaires- Collects and prepares ordered specimens for laboratory analysis- Cleans and sterilizes instruments- Ensures patient exam rooms are stocked, clean, and orderly

- Manage portfolio of key accounts and strategic growth accounts- Maintain and expand product lines of customers to meet company objectives- Maintain a new business opportunity pipeline and facilitate new business opportunity vetting meetings- Lead and manage commercialization process for new product development for key accounts from conception to production- Successfully managed two whole line repackages and bulk changes affecting multiple distribution channels

- Lead and manage commercialization process for new product development for key accounts from conception to production- Identify and mitigate issues that pose risks to project plans- Facilitate internal meetings between cross functional teams to ensure all deliverables for a project are met- Ensure project completion in accordance to timeline and customer specifications

- Manage portfolio of accounts and customer satisfaction- Maintain and expand product lines for clients- Project management of customer products from inception to production and shipping- Creation of a production schedule and tracking of components and production

- Creation and statistical analysis of validation protocols and reports- Adjudication and tracking of Change Control requests and Corrective Action/Preventive Action responses- Extensive quality finished good specification writing and approval- All tasks associated with Quality Assurance Specialist I without direct supervision

• Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.• Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance.• Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.• Perform training and manage the Quality System’s Training Program.• Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).• Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.• Evaluate responses to Incident reports, CAPAs and perform follow-up with respondents, or others, if needed, to ensure resolution.• Make changes to SOPs, policies, training materials, and other documents in the records management system.• Assist during regulatory inspections.• Interface with various Divisions in problem resolution, and continual improvement.-Building Quality Systems programs-Training of employees (OSHA, FDA, DOT, Procedures)-Release of OTC Batches

- Instructed GMP courses - Developed, reviewed, and approved training materials- Conducted investigations and deviations, CAPA and change controls related to laboratory training - Use of programs including TrackWise, LMS Space, Captivate, and SharePoint- Emphasis on training and conducting of cGMP, industry practices, Quality Control and Quality Assurance- Develop and implement training systems for GMP use

- Prepare and run samples using HPLC, dissolution units, FTIR and other instrumentation techniques- Integration and processing of samples to determine specification limits of the active ingredients- Use of programs including LIMS, STARLIMS, Empower 2, TrackWise and Calibration Manager - Calibration of dissolution units, thermometers and HPLCs- Certified Laboratory Trainer for laboratory procedures, techniques and instrumentation- Aided in training and laboratory remediation efforts for the company-Checked and reviewed other analysts notebooks to approve samples