Quality Assurance Customer
Resume:
JANICE LYNN MCDONALD
Tanner, AL 35671
Home: 256-***-**** Cell: 256-***-****
Email: *********@***.***; *********@***********.***
PROFESSIONAL SUMMARY
Quality assurance, business management and process control professional with extensive experience in manufacturing environments. Proven ability to manage day-to-day functions of a quality assurance laboratory. Experienced in managing facility update projects and implementing improvements to testing efficiency. Proven experience in ensuring facility regulatory compliance. Self-motivated, highly-organized professional with exceptional communication, development, implementation and problem resolution skills. Technical proficiencies include Microsoft Office Suite products. Primary location: Huntsville, AL.
HIGHLIGHTS OF PROFESSIONAL QUALIFICATIONS
● Written/Verbal Communication ● Project Management ● Problem Resolution
● Regulatory Compliance ● Root/Cause Analysis ● Staff Development
● Statistical Process Control ● Business Excellence ● Process Analysis
● System Coordination ● Solution Implementation ● Team Building
SELECTED PROFESSIONAL ACCOMPLISHMENTS
Managed a $1M departmental budget. Analyzed budget constraints and managed spending for hiring, employee raises, overtime, equipment, training and travel. Result: Managed a department within budgetary guidelines.
Developed and implemented a plan to restructure laboratory equipment and scheduling. Analyzed testing requirements, ordered new instruments, trained staff, delegated routine testing to operations staff, coordinated with staff to develop and implement a 7-day schedule utilizing 8-hour shifts based on a 40-hour work week. Result: Improved chemist scheduling, increased testing efficiency and reduced operating costs.
Communicated with customers to resolve product quality complaints. Communicated with a customer to identify quality problem, visited customer site to identify problem, set-up on-site testing, determined the root cause of the issue and solved the problem by moving testing panels to a clean area to reduce contamination. Result: Improved customer satisfaction and increased reliability of company testing products at the facility.
Ensured facility regulatory compliance. Coordinated with regulatory agencies such as FDA, ADEM, County Health Department, USDA, etc to conduct facility inspections. Identified opportunities to improve facility compliance and implemented changes as required by state and federal regulatory guidelines. Result: Ensured total company regulatory compliance.
Managed a document formatting change project. Analyzed new document requirements, identified document database placement, created reporting methods and ensured changes were updated as company requirements dictated. Result: All documents conformed to company standards.
EDUCATION
Masters-Business, Alabama A&M University, Huntsville, AL
Bachelor of Science-Zoology/Chemistry, Alabama A&M University, Huntsville, AL
JANICE LYNN MCDONALD
19585 McDonald Lane
Tanner, AL 35671
Home: 256-***-**** Cell: 256-***-****
Email: *********@***.***
PROFESSIONAL OBJECTIVE
An administrative quality assurance management position utilizing communication, analytical, implementation and problem resolution skills to improve document functionality and product quality for a manufacturing company or governmental agency.
PROFESSIONAL EXPERIENCE
Qualitest Pharmaceuticals Sept. 2013 to Present
Senior Quality Specialist, GMP Audit
Perform External Vendor Audits
Audit to the following regulations:
21 CFR 210/211 – cGMP in Manufacturing, Processing, Packing or Holding of Drugs and Finished Pharmaceuticals
21 CFR 110 – cGMP Practice in Manufacturing, Packing, or Holding Human Food
21 CFR 11 – Electronic Records: Electronic signatures – Scope and Application
ICH Q7 – Q7A – GMP Guidance for Active Pharmaceutical Ingredients
USP 1078 – GMP for Bulk Pharmaceutical Excipients
Vendor Compliance
Internal Auditing of the Qualitest Facilities
Certified Quality Auditor (CQA)
Cargill, Inc., Memphis, TN January 2011 to Sept. 2013
QA Supervisor
Responsible for scheduling of lab personnel; Ordered supplies and lab equipment
● Directed the activities of 10 employees; Monitored analytical procedures; Implemented new analytical procedures; Conducted Lab Safety Meetings and Communications Meetings
● Served as location Environmental Contact on analytical issues; Monitored lab equipment for compliance
Cargill, Inc., Memphis, TN July 2010 to January 2011
QA Specialist
Responsible for Customer Audits
Documentation
Laboratory Team Restructure
US Department of Commerce April 2010 to July 2010
2010 Census
Clerk
Pay roll administration
Quality Assurance (Fraud Detection)
Cargill, Inc., Decatur, AL
Quality Assurance Manager 2000-2009
● Managed day-to-day activities of a Quality Assurance Laboratory and Quality Assurance for the manufacturing facility
● Responsible for the quality of finished product and final approval for product released to customers; Provided technical support to customers and production staff
● Directed the work of 13 staff members; Scheduled projects for process personnel
● Resolved customer issues; Resolved processing issues; Trained new lab personnel
● Conducted performance appraisals and salary reviews
● Served as location resource of Business Excellence initiatives
● Conducted a Business Excellence audit at Malaysian facility
● Served as a resource for Root Cause Analysis initiatives
● Coordinated with State & Federal regulatory agencies to ensure facility compliance
● Conducted facility audits and resolved customer complaints
● Managed quality systems, i.e. HACCP, SOPs, GMPs, etc.
Quality Assurance Supervisor 1987-2000
● Responsible for scheduling of lab personnel; Ordered supplies and lab equipment
● Directed the activities of 10 employees; Monitored analytical procedures; Implemented new analytical procedures; Conducted Lab Safety Meetings and Communications Meetings
● Served as location Environmental Contact on analytical issues; Monitored lab equipment for compliance
Laboratory Technician 1980-1987
● Conducted wet chemistry analysis
● Responsible for instrumentation troubleshooting
● Communicated results to operations personnel
EDUCATION
Masters-Business, Alabama A&M University, Huntsville, AL
Bachelor of Science-Zoology/Chemistry, Alabama A&M University, Huntsville, AL
CONTINUING EDUCATION
●Supervisory Development ●Human Relations ●Principles of Supervision
OTHER TRAINING
●Dale Carnegie Course for Self Development ● Statistical Process Control
● Water’s Liquid Chromatography School ● Business Excellence
● Louisiana State University Management Training School ● Root/Cause Analysis
● Personnel Practices & Policies ● Interview Training
Statistically Supported Decision making (Lean Six Sigma)
Kaizen (5S, 5 WHY, Operator Care)
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