Toya F.

Part-time role utilizing Operations/Quality experience. Consult with associates who want to own a business or recently started a business. Work to close gaps with established business. Review SWOT analysis of starting a business with potential entrepreneur. Review expenses, profits, and assess business opportunities. Create quality manual/procedures/system.

Ensure smooth execution of operational activities, including laboratory operations (biologicals-tissues, blood, other bodily fluids), facility support, supply chain, and business support. Ensure strict compliance to GLP and cGMP regulations and company quality SOPs by staff. Work with other senior management members to establish operational strategies and metrics to support business growth. Provide leadership in process improvement to improve service quality and reduce operational costs (Oversee purchasing) Collaborate with project management group and quality group to ensure successful and timely completion of customer projects. Establish appropriate matrices to measure the performance of the department. Determine appropriate staffing levels and schedule personnel in accordance with business workload. Responsible for effective hiring, orientation, supervision and training of staff. Performance management including coaching, performance improvement, evaluation and terminations in accordance with company’s guidelines and policies. Conduct training and orientation of new employees in coordination with quality units. Create and review/edit SOPs

Promoted to director-level role after demonstrating a high aptitude for leadership and operational competencies. Responsible for achievement of ISO 17025 accreditation; GMP compliance; project management of new LIMS; review/approval of deviations/CAPAs; business development; management of department budget; employee hiring, onboarding, development, and evaluation; collaboration with current and prospective high-end clients to establish business needs; recommendations to executive team regarding operational opportunities and improvements.

Provided client consultation, sample testing, and chemical analysis for various products to include diesel, biodiesel, gasoline, naphtha, crude, and jet fuel. Investigated non-conformances and performed root cause analysis. Utilized Sapphire technology to compile data and analyze results.

Served as liaison between Federal Drug Administration (FDA) and corporate office. Hired, trained, and developed staff within the Quality department. Performed product, facility, and safety inspections. Trained employees on cGMPs, SOPs, and safety procedures. Resolved customer complaints. Monitored and evaluated trends in the operations of compounding/manufacturing. Conducted batch approval for finished products.

Managed the day-to-day tactical and long-term strategic activities within the business. Leveraged knowledge of customers, market trends and principal to successfully market quality products through quality processes for home and international offices. Recruited and developed new team members. Offered feedback to executive-level management on the effectiveness of strategies, selling programs, and initiatives. Strengthened company’s business by leading implementation of quality of standards. Accountable for customer complaints handling including overall customer satisfaction. Initiated programs, including system validations, under the quality umbrella. Implemented all new standard operating procedures and trained all employees on cGMPs, SOPs, and safety. Conducted employee appraisals. Created departmental budget. Performed chemist duties.