Virginia Vincent Email & Phone Number

Old Lyme, Ct, Us

Old Lyme, Connecticut, United States

Glendale, Arizona, United States

Arizona, United States

Responsible for managing the review of quality systems and compliance in blood services functional areas. A resource to operations on quality issues and performance improvement initiatives through data and process analysis.• Assists with the coordination of workflow, training, and mentoring of support staff.• Conducts data and process analysis activities, including in-depth analysis of deviations and operational performance data. Evaluates for trends and opportunities for… Show more Responsible for managing the review of quality systems and compliance in blood services functional areas. A resource to operations on quality issues and performance improvement initiatives through data and process analysis.• Assists with the coordination of workflow, training, and mentoring of support staff.• Conducts data and process analysis activities, including in-depth analysis of deviations and operational performance data. Evaluates for trends and opportunities for improvement.• Facilitates and leads Six Sigma, Lean, and uses other improvement tools and methodologies.• Leads and participates in process design activities, change implementation, and supports and performs internal assessments within each functional area.• Prepares for and hosts external inspections by accrediting agencies, including management of the APEX website (AABB).• Facilitates Root Cause Analysis, Corrective Action, and Effectiveness Evaluation for deviations.• Performs review of documents to ensure processes are within control (e.g., QC data, Validations, Qualifications, and proficiency testing).Accomplishments:• Collaborated with SW Laboratory Sr. Director, Manager, and Supervisors to implement 5S. Mentored and coached by an OE manager for project success.• Reduced of Laboratory labeling deviations using huddles, visual aids, and weekly status reports.• Reviewed and approved of all functional area validations, especially equipment established after the new center opening.• Redefined the CDC process for units identified with fibrin clots, reducing the time in product evaluation, co-component retrieval, and customer process evaluation. Developed a template/checklist for lab use in customer evaluation.• Manipulation of weekly Compliance Profile to accurately report deviations, highlighting issues in problem areas. Show less

Phoenix, Arizona Area

Responsible for Quality oversight, investigation, and proactive implementation of CAPA methodology within a drug compounding facility.• Ensured finished drug products were sampled, tested, and acceptable as human pharmaceuticals.• Reviewed and investigated drug batch records, ensuring proper resolution of deviations affecting the acceptability of the product.• Implemented corrective action and preventative action (CAPA) associated with product and process failure… Show more Responsible for Quality oversight, investigation, and proactive implementation of CAPA methodology within a drug compounding facility.• Ensured finished drug products were sampled, tested, and acceptable as human pharmaceuticals.• Reviewed and investigated drug batch records, ensuring proper resolution of deviations affecting the acceptability of the product.• Implemented corrective action and preventative action (CAPA) associated with product and process failure investigations.• Evaluated analytical and microbiological laboratory results, ensuring compliance with established regulatory specifications product standards and customer expectations.• Collaborated with Regulatory Affairs, Operation Supervisors, and technicians to ensure current understanding of all rules and regulations (e.g. State Board of Pharmacy, FDA, USP guidelines and OSHA).• Assisted in conducting Internal Quality Assurance Audits, meetings, and training for existing and new programs. Show less

Tempe, Az

Led a diverse group of employees through company growth and consistent change in a highly regulated environment. • Initiated Operational Excellence within the department, having completed management level OE training. Developed metrics to measure and evaluate the department’s productivity and work quality.• Actively participated in project teams creating, updating, and improving manufacturing processes, departmental procedures, and SOPs used company wide. This included the analysis of… Show more Led a diverse group of employees through company growth and consistent change in a highly regulated environment. • Initiated Operational Excellence within the department, having completed management level OE training. Developed metrics to measure and evaluate the department’s productivity and work quality.• Actively participated in project teams creating, updating, and improving manufacturing processes, departmental procedures, and SOPs used company wide. This included the analysis of data and processes for performance improvement investigations.• Considered a subject matter expert in processes associated with donor eligibility determination, automated procedure review, and process improvement/development. • Completed Deviation Management entry, investigation, and resolution utilizing the DMAIC process.• Managed electronically stored documents (scanned, reviewed, signed, modified, and sent for permanent storage).• Developed staff scheduling to support department success in meeting deadlines and optimized department efficiency to address fluctuating workloads. Show less

Tempe, Az

Participated in a pilot department structured around electronic document review. Critical towards the implementation of electronic document review and permanent storage of highly confidential medical information. • Excelled in Electronic Document Review with minimum errors (avg. > 100 recs/hr.).• Evaluated and resolved the Potential Duplicate Donor Report along with investigating cases opened.• Performed Market Withdrawal procedures, including the investigation of Post Donation… Show more Participated in a pilot department structured around electronic document review. Critical towards the implementation of electronic document review and permanent storage of highly confidential medical information. • Excelled in Electronic Document Review with minimum errors (avg. > 100 recs/hr.).• Evaluated and resolved the Potential Duplicate Donor Report along with investigating cases opened.• Performed Market Withdrawal procedures, including the investigation of Post Donation Information (PDI). As needed, performed product retrieval and consignee notification. Actively investigated Recalls associated with Donor Services.• Quarantined, investigated, and performed resolution (destruction/release) of potentially unsuitable blood and blood components.• Supplied immediate guidance to donors contacting the department with post donation reactions and information. Show less

Scottsdale, Az

Responsible for record review of confidential documents and management of QMS.• Evaluated, entered, and completed the Deviation Management (DMAIC) process within the QMS system.• Performed Record Review of confidential documents per FDA/AABB regulations: o Medical Health History Questionnaires o Automated Machine Records (ALYX, TRIMA, SPECTRA, & HAEMONETICS) o Quality Control Records for both equipment and supplies• Maintained… Show more Responsible for record review of confidential documents and management of QMS.• Evaluated, entered, and completed the Deviation Management (DMAIC) process within the QMS system.• Performed Record Review of confidential documents per FDA/AABB regulations: o Medical Health History Questionnaires o Automated Machine Records (ALYX, TRIMA, SPECTRA, & HAEMONETICS) o Quality Control Records for both equipment and supplies• Maintained manual storage, boxing, and shipment for permanent storage of confidential documents. Show less

Phoenix, Arizona Area

Evaluated donor qualifications for blood donation and performed whole blood phlebotomy within FDA/AABB guidelines.• Fluent in SOPs to determine donor eligibility for blood donation.• Completed machine QC, temperature monitoring, and storage/shipment of blood and blood components.• Performed phlebotomy for donation types: WB Allogeneic, Autologous, Therapeutic, and vacutainer draws.• Monitored and treated post donation reactions.

Phoenix, Arizona Area

Direct customer service position within the donor center. Responsible for donor flow, scheduling, and conversion of donors to automated procedures more beneficial to their individual blood type.• Acquired great customer service skills while learning the inner workings of a blood center.• Organized blood donor promotions, monitoring distribution of and accountability of prizes.

Master Of Health Administration, Health/Health Care Administration/Management

Bachelor Of Science - Bs, Management

Associate Of Arts - Aa, Psychology