Toni Stephens

• Receive, prioritize and analyze raw material samples
• Effectively and efficiently enter and data gathered from testing
• Maintain paperwork generated as a result of analysis
• Maintain, update and write SOP's
• Review and enter Certificate of Analysis data from vendor documents
• Attend weekly inventory review meetings
• Track issues with inventory system (JDE) and contact IT for correction
• Enter non-conformance information into TraceGains database
• Investigate non-conforming material and report findings to appropriate parties
• Communicate effectively throughout departments to report issues with materials or release early when needed to meet demands
• As a member of the site safety committee, participated in safety committee meetings, audited assigned labs and reported findings back to the committee for improvements
• Maintain CoA and sample trackers
• Follow up with other teams to address missing samples or documentation
• Investigate delays to find the root cause and assist with rectification
• Lead fellow team members in prioritizing samples and improving overall lab performance
• Assist or train other colleagues whenever needed
• Log and ship out samples that require testing by a third party lab
• Maintain reports generated from external lab testing
• Log and deliver samples to other labs within the company
• Follow up with internal or external labs when results are not received in a timely manner
• 3 years 4 months

Verify and calibrate lab instruments daily
Maintain paperwork generated by daily testing
Communicate effectively with management and colleagues to ensure smooth
processing of data
Prioritize and analyze in-process samples
Report results in a timely manner to support production
Confirm, investigate and report failures
Provide and review end of shift reports for smooth transition between shifts

• 1 year 10 months

• Prioritize and analyze quality control samples including incoming raw materials, in-process samples, and rinse out samples using HPLC and GC, as well as other various analytical instrumentation.
• Independently analyze and report assay results to customer in a timely manner, as well as creating/modifying Excel spreadsheets for the recording of all data generated in the QC lab.
• Responsible for creating SOP's and modifying analytical methods for HPLC and GC as needed.
• Represent the Quality Department as an active member of both the 5S Sustainment Team and the Safety Team.
• Lead IDQC Mold Reduction Team for optimization of MC susceptible formulations.
• Strong familiarity with GLP and GMP compliance requirements.
• Perform Microbial testing on susceptible products and materials.
• Maintain QC lab, including ordering supplies, labeling materials accordingly and disposing of hazardous waste.
• Regularly check in-process production lines to ensure conformance with all specifications.
• Inspect incoming components and materials per specification.
• Verify work orders prior to production and handle all paperwork once complete.
• Provide manufacturing lines with required paperwork and labels for each run.
• Investigate and manage non-conformances on incoming materials as well as products manufactured on site.
• Assisted in achieving record closure rates in June 2018.
• Participate in Root Cause Analysis when applicable.
• Initiate Management of Change when applicable.
• Create, implement use and maintain SOP's
• 14 years 8 months

• Operated many different types of machinery on multiple production lines, including, but not limited to fillers, labelers, cappers, and box and bottle coders.
• 1 year