Sheila Cash

About Sheila Cash

Quality Assurance professional with experience in research and development laboratories, manufacturing (including cannabis industry) and packaging facilities that are small to major consumer products companies both nationally and internationally. Proven skills in Quality Assurance and Quality Control which includes: lead internal, supplier, and external auditing, continuous improvement, analyzing data and performing biological and analytical testing. Proactive, results oriented professional with strong knowledge of regulatory, statutory and industry compliance, excellent technical and communication skills. Demonstrated leadership skills within a corporation or community service organizations performing multiple tasks independently or as a member of a team. Interested in quality control, quality assurance, regulatory and compliance for food, drug, medical device, and chemical industries.

Experience

1. Quality Assurance Deviation Investigator

   Oxford Global Resources

   Oct 2021 — Present · Bradley, IL, US

   Technical writer lead investigation owner for current deviations in fill finish from initial risk assessment (IRA) to investigation closure with root cause analysis (RCA) defined for aseptic pharmaceutical manufacturing environment production across production lines defining corrective actions and preventive actions (CAPAs)•Perform audits of aseptic process/behaviors of filling lines, isolators, restricted access barrier systems (RABS), validation and operations to triage findings through aseptic techniques and aseptic interventions within pharmaceutical manufacturing of lyophilized product, syringes, liquid product and vials•Assist with deviation backlog closures in the fill finish department to ensure efficiency•Utilize various programs and systems like TrackWise, STAR LIMS, and SAP to complete and support deviation closure•Matrix Manager between multi-disciplinary teams to gain consensus of true root cause for continuous improvement in the manufacturing process while following good manufacturing practices (GMPs)

Education

• National Environmental Health Association

  Hazard Analysis Critical Control Point Managment Training

  2013

• R.J. Reynolds Tobacco Company and Area Community College

  Corporate Professional and Development Training Courses

• North Carolina Agricultural and Technical State University

  Bachelor of Science - BS, Chemistry

• Safe Quality Food Institute

  SQF Lead Auditor Training

  2014

• SAI Global (formerly Excel Partnership)

  Lead Internal Auditor Certification Training

  1999

Skills

• Qms
• Trackwise
• Quality System
• Technology Transfer
• Analytical Techniques
• Lead Internal Audit
• Manufacturing Operations
• Analytical Chemistry
• Cgmp
• Hplc
• Powerpoint
• Gc-Tea
• Mentoring
• Iso
• Sop
• Fda
• Lims
• Goal Oriented
• Coaching
• Pharmaceutical Manufacturing
• Microsoft Office
• Gas Chromatography
• Customer Service
• Gfsi
• Usda
• Capa
• Sqf
• Quality Control
• Research
• Gmp
• Quality Management
• Quality Auditing
• Glp
• Gc-Ms
• Quality Assurance