Pharmaceutical Quality Manager with over five years of management and laboratory experience. Responsible for all aspects of quality control and quality assurance in the manufacture of pharmaceutical grade barium sulfate to ensure overall compliance. Led remodel of the Quality Department prior to initial FDA inspection resulting in zero form 483's issued.
Knowledgeable and Compliant with FDA , MSHA, and 21 CFR part 210 and 211 regulations.
Developed and implemented Annual Product Review and Management Review.
Demonstrated excellence in communication skills with various levels of state and federal regulators.
Manage Active Pharmaceutical Ingredient laboratory.
Evaluate and approve raw material suppliers.
Provide accurate documentation of statistical reports.
Review and approve Out of Specification (OOS) investigations, Deviations, CAPAs, and Change Controls per cGMP procedures.
Manage client correspondence from project initiation to site audits.
Proficient in Microsoft office.
Coordinate and perform raw and finished good inventory management.
Trained in Salesforce and ERP.
Recommend and implement corrective actions.
Quality Manager, 05/2012 to Current Cimbar Pharmaceutical – Chatsworth, GA
Manage FDA compliant Quality department and laboratory to ensure compliance with quality polices, procedures, and systems.
Redesigned the Quality unit to meet federal regulations while reducing operating cost.
Review, approve, and implement raw material and finished product specifications.
Manage Quality Control equipment validation and calibration activities.
Manage QA and QC team, assign responsibilities, interview, hire, and assist with training new employees.
Review and approve quality and analytical standard operating procedures and supplemental forms.
As a member of the management team, set annual goals and continuous improvement initiatives.
Optometric Technician, 05/2007 to 04/2012 Advanced Eye Care – Chatsworth, GA
Conducted pretesting procedures with patients.
Assisted the optometrist with visual acuities.
Fitted and adjusted eyeglasses and contact lenses.
Maintained and updated patient records.
Maintained materials inventory.
Trained colleagues in new employment positions, assigned and monitored tasks.
Bachelor of Science: Biotechnology, 2012 Kennesaw State University - Kennesaw, GA
Magna cum laude
Coursework includes General Chemistry, General Biology, Organic Chemistry, Biochemistry, Physics, Genetics, Calculus, Accounting, Conception to Regulatory Approval.
Attended Study abroad Global Biotechnology course at Institut Pasteur in Paris, France.