Alisa Wilson

*** * *** * ******, UT *****

801-***-**** act4m1@r.postjobfree.com

CAREER SUMMARY

Quality Assurance … Measuring adherence to defined standards and guidelines with a detail oriented focus. Facilitating collaborative efforts toward a common goal of measurable product quality. Expertise in training others, audits, reviews, compliance, and development of procedures. Enjoy seeing a project through to completion and adapting to new challenges.

NOTABLE ACCOMPLISHMENTS

Led my shift to achieve 97% Right the First Time annually for paperwork for in-process inspections which contributed to the overall team achievement of 93% Right the First Time

Train and mentor my shift and many team members from other shifts on an on-going basis.

Champion change among the team.

Work well with others, even when there are different priorities in question

Learn quickly and enjoy the challenge of new projects and opportunities

PROFESSIONAL EXPERIENCE and SELECTED ACCOMPLISHMENTS

E-EXCEL, Sandy, UT 2013-2015

Dietary supplement manufacturer which supplies a network marketing company. Staff: 50

Quality Manager (2013 - 2015)

Managed the Quality Department serving 40 individual products. Responsible for the final quality of all products sold. Managed manufacturing deviations and investigations. Managed investigations resulting from customer complaints. Worked with co-packers to ensure their compliance with our company goals and requirements.

Directly managed staff of 2.

Trained staff to increase quality skills including: updating Standard Operating Procedures, training manufacturing staff, improving programs, auditing, investigating deviations and non-conformances.

Launched new products and reformulated products. Ensured testing, labeling and ingredients were acceptable prior to all product launches.

Created and improved Standard Operating Procedures and programs ensure compliance with FDA issued 21CFR (Code of Federal Regulation) Part 111.

CEPHALON INC (acquired by Teva Pharmaceuticals, 2011), Salt Lake City, UT 2009 - 2013

World’s largest pharmaceutical manufacturing company specializing in generics. Site: 350 employees. Cephalon annual revenue: $3.1B. Teva annual revenue: $18B.

Quality Assurance III (2011 – 2013)

Mentor and train new team members on inspections, reviews, and Standard Operating Procedures (SOPs). Assess compliance and deficiencies of production by performing weekly inspections, line clearances (3 per week) and managing labeling materials (2-3 per week). Review artwork for accuracy and completeness. Create and update SOPs as needed to address system changes or gaps. Review and release raw material files containing all commercial product paperwork, including ingredients, certificates of analysis or compliance, and lab test results. Perform risk analysis audits.

Led my shift to achieve 97% Right the First Time annually for paperwork for in-process inspections which contributed to the overall team achievement of 93% Right the First Time.

Developed work instructions to standardize the way in-process inspection paperwork is filled out in relation to exceeded AQL inspections.

Developed SOPs outlining the activities required to place a product, piece of equipment, room or area on QA Hold to prevent its use.

Led trainings for packaging and manufacturing staff on GMP related topics and line clearance training procedures.

Initiated project to create on-network library of examples of properly executed forms.

Building a training protocol to teach the philosophy and methodology of AQL inspection forms.

Quality Assurance II (2009 – 2011)

Performed 8-14 production inspections per day, 2+ line clearances per day, and prepared labeling materials 2-3 times per week. Reviewed artwork for accuracy and completeness. Reviewed and released raw material files containing all commercial product paperwork, including ingredients, certificates of analysis or compliance, and lab test results.

Developed spreadsheet to document and track the artwork review process, and to maintain metrics on the artwork process, in order to identify and quantify problems.

Promoted to Quality Assurance III in 2009.

E-EXCEL, Sandy, UT 2007 - 2008

Dietary supplement manufacturer which supplies a network marketing company. Staff: 50

Quality Manager (2008)

Managed the Quality Department serving 20 individual products. Responsible for the final quality of all products sold. Managed the day to day issues that arose between Quality Department, and the production and purchasing departments. Monitored, approved, and managed storage of paperwork, including completed batch records, SOPs, and Certificates of Analysis. Worked with co-packers to ensure their compliance with our company goals and requirements. Continued to perform duties of Quality Control Technician.

Directly managed staff of 2.

Learned Spanish in order to communicate effectively with Quality Department staff.

Negotiated and facilitated communications with production and purchasing departments, to reach agreement upon quality goals and regulatory compliance objectives.

Created over 15 Standard Operating Procedures and programs to address FDA issued 21CFR (Code of Federal Regulation) Part 111, effective in 2007. SOPs addressed facilities, pest control, MSDSs, Good Manufacturing Practices in areas such as warehouse, label control, and production.

Quality Control Technician (2007 – 2008)

Assisted with procedure upgrades and in maintaining current SOPs. Performed AQL’s to ensure quality on incoming materials from which we built the finished products and outgoing finished products.

Filled in where required, performing lab work, in-process inspections, and assisting in the management of labeling materials as well as retains.

Compiled information to maintain good relationships with 6 different countries in which E. Excel sells products.

Coordinated with production and purchasing departments, along with co-packers, to facilitate product delivery according to acceptable standards.

Initiated lab work to update the Nutrition Facts tables on 7 different products sold in the US and Canada.

Promoted to Quality Manager in 2008.

SORENCO LABORATORIES, Salt Lake City, UT 2006 - 2007

Privately owned co-packer primarily for dietary supplements and cosmeceutical. Staff: 350-400

Quality Control

Performed lab testing as well as ensured the quality of products produced to meet the ultimate goal of creating uncontaminated products and in a timely manner based on Good Manufacturing Processes. Ensured production procedures met criteria required to maintain SOPs. Ensured production procedures followed the correct order, and the proper paperwork was completed. Rejected bad products and parts, as needed.

Communicated and coordinated with management, production lines, account managers and compounders.

EDUCATION, TRAINING and CERTIFICATION

Salt Lake Community College, Salt Lake City, UT

Associate of Science

CQI (Certified Quality Inspector), ASQ, Salt Lake City, UT 2011

CQIA (Certified Quality Improvement Associate), ASQ, Salt Lake City, UT 2010

TECHNICAL/COMPUTER SKILLS

MS Office, including Word, Excel, PowerPoint, Outlook

Inventory tracking software, including SAP

Standard Operating Procedures document management systems, including QDocs

Trackwise change control software

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