Quality Assurance Specialist I

Lewes, DE

Summary

As a team member of the Quality group, helps to ensure that the site follows all Federal, State and company mandated quality compliance programs with emphasis on proper GMP documentation and GMP auditing.

 Essential Duties and Responsibilities

  • Ensure site awareness of quality standard operating procedures (SOPs) and (cGMP) Regulations
  • Liaison with production as a representative for the quality program with special emphasis
  • on proper GMP documentation and auditing
  • Problem Resolution
  • Perform some good manufacturing procedures (cGMP) training to internal staff.
  • Complete quarterly GMP audits and assist with Quality System audits as directed by the Quality Assurance Supervisor.
  • Provide a Quality presence in the production area while being the liaison with production employees for GMP compliance. Make recommendations for improvements.
  • Review and approve batch records and labels after generation
  • Review in-process batch records and production test pages, logbooks and housekeeping practices
  • Disposition of finished products, raw materials and packaging materials
  • Final review of campaign checklists, logbooks, test data and batch records, along with maintaining batch record metrics

 Education, Skills and Experience

  • Bachelor’s degree in Science required and/or 1-3 years of equivalent work experience within the pharmaceutical or chemical industry OR High school diploma or G.E.D with 2 years quality experience within the pharmaceutical or chemical industry or equivalent combination of education, training and experience
  • Experience with typical Quality projects such as current Good Manufacturing Practice (cGMP) documentation review/approval, auditing, product and raw material release, change control, investigations, and training
  • Ability to plan and manage multiple priorities / projects
  • Ability to work with all personnel in a tactful manner
  • Attention to detail
  • Problem analysis and problem resolution skills
  • Excellent interpersonal and communication skill.
  • Strong team player
  • Ability to act independently when handling recurring issues
  • Ability to learn and adapt quickly to new situations and/or priorities
  • Meet project deadlines
  • Displays initiative and technical commitment