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Quality Assurance Compliance Specialist

  Irwindale, CA,  United States |  Full time

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Posting Date :  2022-01-03

Job Identification :  10943

Department  :  Quality Assurance

Reporting to the Quality Compliance Supervisor, is responsible for supporting manufacturing by ensuring that performance standards and procedures are followed, and audit controls are in place in order to meet business requirements. The Quality Compliance Specialist will assist Quality Compliance Supervisor in maintaining Quality Systems (such as Investigation System, CAPA System, Complaints System) and performing primary batch record review prior to final release approval

Key Responsibilities:

  • Maintains Investigation, CAPA, Complaints, Change Control systems logs.
  • Leads and reviews investigations (deviations, excursions, complaints). Ensures CAPAs are assigned and followed through.
  • Perform primary quality batch record review.
  • Assists in the preparation for Health Authority inspections and audits and provides support to their execution and follow-up.
  • Review and approval of quality related documents.
  • Assists in collection of data for Annual Product Reviews.
  • Writes Annual Product Reviews.
  • Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results.
  • Monitors Quality Systems and advises Quality Compliance supervisor on system performance; publishes statistics regarding performance against set goals and makes recommendations.
  • Trending of Quality metrics.
  • Performs trainings on various GMP related topics as needed.
  • Other duties as assigned.

Requirements:

Education/Experience

  • Bachelor's degree in sciences or related field required, Bachelor's degree in Microbiology preferred
  • 2-3 years’ relevant experience in a regulated Pharmaceutical industry including Quality Systems, Quality Assurance, Quality Control.
  • Experience in an aseptic manufacturing facility is desirable
  • Combinations of related education and experience may be considered Technical/Behavioral
  • Knowledge of cGMP, Quality Systems (CAPA, Investigations, Complaints, Change Control), Drug Regulatory Affairs, manufacturing and packaging processes required.
  • Knowledge of process validation, microbiology and chemistry preferred.
  • Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
  • Ability to communicate effectively defending quality initiatives and compliance a plus.
  • Good command of the English language required. Fluent in any other languages a plus.

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