Guest Supply, LLC

Quality Assurance Specialist II

1 month ago(11/16/2017 10:37 AM)
Job ID
# of Openings


Perform Quality Assurance (QA) activities to build, maintain, and improve the Company’s Quality Assurance Management Plan. Perform at an experienced and functional level therefore requiring limited supervision.


  • Support the Quality System infrastructure by performing QA tasks pertaining to documentation of processes.
  • Perform Good Manufacturing Practices (GMP) compliance tasks, including audits, and documentation maintenance. 
  • Perform internal supplemental audits to verify that facility records files are in conformance to applicable Standard Operating Procedures (SOP) and GMP regulatory requirements.
  • Perform training and manage the Quality System’s Training Program.
  • Ensure documentation systems used in QA are properly maintained (e.g., QA audit records, training records).
  • Perform protocol, data, and report inspections to verify conformance to applicable SOPs and GMP regulatory requirements.
  • Evaluate responses to Incident reports and perform follow-up with respondents, or others, if needed, to ensure resolution.
  • Make changes to SOPs, policies, training materials, and other documents in the records management system.
  • Assist during regulatory inspections.
  • Interface with various Divisions in problem resolution, and continual improvement.
  • Support manufacturing failure investigations, define investigational strategy.
  • Perform other duties as assigned.


  • Bachelors degree or equivalent experience.
  • Minimum 3 years experience in and Food and Drug Administration (FDA) regulated manufacturing environment.
  • Minimum 1 year experience training in a business setting.
  • Minimum 3 years of progressive experience in Quality Assurance
  • Project management experience.
  • Experience training safety, quality and GMPs.
  • Demonstrable strong written and verbal communication skills.
  • Excellent organizational skills.   
  • Proven record of excellent documentation skills.
  • FDA & OSHA trained and familiar with current regulations.
  • Strong problem solving skills.
  • Project management and technical software skills in Microsoft Office Suites required.
  • Work well under pressure and able to prioritize workloads.
  • Ability to perform risk assessment.
  • Experience fostering teamwork to get results.
  • Well organized and multi-task oriented.
  • Ability to work independently on multiple projects.
  • Ability to read, write and speak English competently.
  • Worked in pharmaceutical or cosmetic manufacturing environment.
  • American Society for Quality certifications preferred.


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