Dedicated and incisive Quality Assurance Specialist eager to contribute significant experience, scientific background, and outstanding leadership talents toward supporting a dynamic organization in achieving business goals and objectives.
Advanced knowledge of and experience with GMP (good manufacturing practice) and GLP (good laboratory practice).
Demonstrated ability to set up, implement, and manage comprehensive quality systems, interpret complex specifications, and devise quality procedures and work instructions.
Adept in use of Smart CAPA software for corrective action and quality management.
Proficient at compliance document preparation, approvals, training, and validation.
Proactively establish a cooperative climate across multiple departments, and able to identify opportunities which will result in long-term benefits for the employer.
Excel in delegating assignments, supervising staff, team-building, and training and recertifying personnel.
Exemplary blend of prioritization, troubleshooting, report writing, and analytical thinking skills.
Able to precisely define goals, uncover challenges, propose modifications, and drive solution implementation to achieve measurable and immediate quality improvements.
United Therapeutics, Durham, NC, 2009 to Present
QA Specialist (Contractor)
- Proficiently review, edit and approve SOP (standard operating procedure), document and coordinate SOP training, and steer SOP change control via databases and spreadsheets.
- Apply sharp attention to accuracy toward sampling raw materials and components for manufacturing approval, issuing and tracking operational deviations, and verifying logbook data.
- Diligently examine and decisively issue batch records for product release and distribute controlled components for product packaging.
- Play an integral role in creating SOP specific to Quality Assurance department.
Hospira Inc., Clayton, NC, 2008 to 2009
QA Specialist (Contractor)
- Tasked with performing comprehensive auditing of batch records for pharmaceutical products and conducting meticulous packaging line inspections to ensure quality and compliance.
- Trained, mentored, educated and supervised line supervisors and technical staff in appropriately documenting GMP.
- Participated in FDA/client inspections, and drove unified efforts among all departments to ensure appropriate GMP/GLP documentation.
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Professional Experience continued
PPD, Morrisville, NC, 2008
Research Associate III (Contractor)
- Supported in vivo efficacy evaluation by providing standard and customized study designs and screening methods for investigational agents.
- Conducted non-clinical tumor studies involving breast, colon, epitheloid, fibrosarcoma, gastric, and glioma.
- Trained and/or recertified preclinical research associates working with mice and rats in dosing methods (oral, intravenous, subcutaneous, intraperitoneal), and tumor fragment/cell implantation.
Pfizer Global R&D, Groton, CT, 1994 to 2007
Senior Research Associate / Quality Assurance / Quality Control Specialist
Spearheaded quality assurance and control by inspecting GLP studies to ensure protocol compliance, participating in consensus meetings to ensure accuracy of draft final report, scrutinizing final report, and preparing and distributing detailed findings.
Demonstrated exceptional attention to details in reviewing batch records for Citric Acid production to validate GMP.
Drove research initiatives by scheduling and coordinating broad-based GLP and non-GLP nonclinical study protocols, documenting study instructions and activities, and implementing study protocols.
Expertly administered test vehicles and compounds by oral gavage, in-feed, and injection (intravenous, subcutaneous, intramuscular and/or intraperitoneal) in mice, rats, canines, and non-human primates.
Closely observed, measured, assessed and recorded clinical data from test animals inclusive of body weight, food consumption, vital signs, and blood pressure.
Collected biological samples from test animals, administered electrocardiograms, and performed in-depth physical exams in strict accordance with protocol instructions as well as SOP and GLP guidelines.
Instrumental in assessment, updates and revisions to SOPs and SOP forms, training documents, QC guidelines, and computer software used for data acquisition or scheduling.
Conducted canine and non-human primate electrocardiogram and blood pressure acquisition via PONEMAH data acquisition system.
Exercised strong leadership talents in delegating personnel assignments related to use of PONEMAH acquisition systems.
Recognized as department expert in troubleshooting PONEMAH technology and qualified to train and recertify users in system use.
B.S., Laboratory Animal Science, North Carolina A&T State University
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