Kacie C. Golden
Mayfield Heights, Ohio 44124
Quality Assurance professional with 11 years of experience. Experience with FDA, ISO, JCAHO, and CMS regulations. Experience working with Trackwise, Oracle, Agile, MFG/PRO, Mercury, Lotus Notes, Facets, Fazal, Marx, and MS Office.
University of Phoenix, Cleveland, Ohio
Master of Health Administration
Xavier University of Louisiana New Orleans, Louisiana
Bachelor of Science in Biology
CVS Health Solon, Ohio
Quality Control Manager Production Services (March 2014-present)
Oversee department work flows while ensuring that all requests are processed within stated timelines in compliance with quality standards.
Coach/Develop staff of 15 to achieve quantitative and qualitative performance targets.
Collaborate with staff to identify internal and external customers and their expectations, initiate process changes to increase quality, improve staff, provider and member satisfaction.
Review and analyze reports, records and directives, and confer with staff to obtain data required for planning work function activities.
Use data and insights to coach and manage for optimal performance.
Explore new approaches to work processes by utilizing quality improvement techniques to eliminate waste and re-work.
Establishment of the departmental strategies and objectives.
Manage the Data Validation of member ID cards, enrollment, disenrollment, COB surveys, LIS, LEP, and many other communications.
Works closely with the enrollment team, premium billing, and other business teams to ensure eligibility and enrollments for members are correct and all communication is submitted and mailed in a timely manner.
Manage the premium billing review and validation for members.
Interview and hire personnel for the team.
Analyze data for specific projects and report to all levels of management.
Analyze and report on operational activities and metrics.
Conduct data analysis to describe trends, anomalies, successes or issues. Implement Changes to process or procedures as necessary to achieve goals.
Provide third party audit support as needed.
Perform periodic quality control checks on communications and ensure stakeholder accountability for quality.
Lead and Manage Special projects throughout the company and department. Ensure all member issues are resolved and addressed.
Quality Control Supervisor Production Services (August 2013-March 2014)
Supervised a staff of 8 individuals, evaluated performance of each individual and provide relevant feedback.
Conducted data validation on inputs that trigger member communications including identifying high risk data files.
Ensured data files are produced in accordance with approved business logic rules
Assisted in developing standards for data file quality validation
Evaluated whether communication data inputs fulfill requirements, resolve issues efficiently, and work with stakeholders on issue escalation when adjustments are necessary.
Developed a strong working knowledge of CVS Caremark’s Member Communications Operations processes including implemented technology.
Reviewed and make recommendations on standardized processes across the team to continuously drive to better on-time and on-budget outcomes.
Ensured that all communication data inputs are evaluated with consistency, reliability and accountability for CVS Caremark clients and members.
Invacare Corporation Elyria, Ohio (April 2013-August 2013)
Sr. Supplier Quality Engineer (Temporary Contract Position)
Performed investigations for Supplier Quality complaints. Closed more than 20 complaints daily.
Decreased the supplier quality back log by over 40%.
Open and close complaints and needed. If needed open SCAR and other documents needed to complete the investigation.
Assisted with process improvements and supplier quality issues.
Performed desk audits for potential suppliers and re-audits for preferred vendors.
Assisted with implementing all new initiatives for supplier quality based on consent decree that was in place by the FDA.
JALEX Medical, LLC Westlake, Ohio (October 2012-March 2013)
Quality Assurance and Regulatory Affairs Specialist
Implemented Quality Management Systems and developed quality management systems for medical device companies. This included but was not limited to creating procedures, work instructions, policies, and plans. Creating and implementing training for company employees.
Performed Internal Audits for clients in preparation for FDA or other regulatory agency audits, and compliance. Assist clients with readiness audits in preparation for upcoming FDAS and other agency inspections.
Performed predicate device research for 510(k) submission.
Assisted with FDA remediation assistance for 483 observations and warning letters of 4 clients, by acting as Quality and Regulatory representation. In addition answering FDA 483s and Warning Letters.
Created and performed specific site training programs including but not limited to ISO 13485, FDA, CMDR, MDD, Good Documentation Practices, and Good Manufacturing Practices for 2 clients.
Phillips Healthcare Highland Heights, Ohio (November 2010- December 2012)
QA/ RA Complaint Investigator II
Managed Service Order Review process for the US and Globally.
Reviewed over 3,000 service orders for complaints and potentially reportable complaints and enter into all complaints into Trackwise. Determined if complaints were reportable and should be forwarded to the MDR/Adverse Events manager.
Performed investigations for complaints as entered into the system. Follow up with the facility, field service engineer, or end user that called in complaint as necessary.
Reported the number of service orders received, reviewed, and entered as complaints into Trackwise monthly and for the quarterly management review. This included trend analysis, most frequently occurring complaints, and the number of complaints opened and closed at any point in time, and trending of complaints by business unit.
Back-up for CAPA process (implementation, monitoring, and completion)
Assisted in streamlining the complaint process and decreasing the time for completion and entering complaints into the system to 2 days form 5 days.
Lifebanc, Cleveland, Ohio (December 2009-November 2010)
Quality Assurance Coordinator
Audited Records in a timely manner (very quick turnaround time)
Analyzed and distributed data to all other reporting bodies and vendors.
Problem solved as a group and as an individual.
Accepted or Rejected materials and supplies.
Audited the facility, labs, and external vendors.
Trained individuals in FDA and AATB standards.
Trained individuals on company Procedures and Protocols.
Wrote and revised Standard Operating Procedures.
Prepared weekly and monthly updates to entire company for record review and quality issues
Implemented ideas for continuous improvement.
Ricerca Biosciences LLC Concord, Ohio
Quality Assurance /Regulatory Affairs Auditor I (July 2007-July 2008)
Quality Assurance /Regulatory Affairs Auditor II (July 2008-December 2009)
Audited Master Batch Records, production processing records, process activities, validation activities, labeling, and release data for compliance with applicable cGMP and ICH Q7A and Ricerca procedures; reporting audit findings and maintaining appropriate QA records.
A constant guide and leader when it pertains to production records, documentation, and facility compliance. Assist in implementing continuous improvement ideas.
Created in process inspection procedure and performed onsite in process inspections for all project with a large focus on process and documentation. When necessary issue deviations, investigations, or have errors and issues correct as discovered. Audits were performed as deemed necessary by the Standard Operating Procedure or by the request of the client.
Maintained knowledge and understanding of applicable ICH Q7A for Active Pharmaceutical Ingredients and cGMP regulations, standards, and/or guidance.
Wrote, reviewed, and /or updated the Quality Assurance Manual, Standard Operating Procedures, Work Instructions, Test methods, validation plans (etc.).
Reviewed and approved analytical test methods and release specifications for raw materials, containers/closures, in-process materials, and final products. This includes validation protocols and reports.
Assisted in the hosting of FDA audits, and weekly client audits and visits as lead auditor and part of the backroom. Correct action items that are a result of the audit or inspections.
As needed, inspected and audited various phases of GLP studies to ensure compliance with protocol, protocol amendments, standard operating procedures, and Ricerca policies. Report deviations and maintain appropriate QA records (animal facilities). Correct audit findings.
Released and Rejected intermediates and final Active Pharmaceutical Ingredients.
Perform investigations, deviations, changes, and MRBs (material review board) when deemed necessary.
Trained personnel on GMPs, GDPs, GLPs, and all procedures and processes as necessary. In addition preparing the facility and personnel through readiness audits for client and regulatory body future inspections.
Participated as a member of the vendor and supplier quality team that approved and rejected vendors and suppliers.
Ben Venue Laboratories Inc. Bedford, Ohio (September 2005- July 2007)
Quality Assurance Auditor I
Audited aseptic filling processes, insuring compliance to SOP and cGMP.
Monitored the formulation, filling, packaging, and distributing of drugs made on site, as well as documentation of all processes. Inspect documentation in batch record and any quality documentation.
Ensured all corrections are complete and records for production are accurate.
Communicated with customers and all employees.
Problem solved and implemented process improvements as a member of specific teams.
Performed calculations and basic statistics.
Organized data using excel sheets and word documents.
Trained in sterile room technique and process, and trained in clean room techniques.
Wrote Reports and Issued Deviations for investigations as necessary.
Performed investigations for specific lots when needed, or after facility audits performed on a nightly basis.
Ensured all processes, protocols, and records are done according to SOPs and cGMP regulations.
Internal facility audits and writing audit or observation reports for each audit performed (Includes all areas of production and labs).
Interacted with all levels of individuals in the company.