Senior Quality Assurance Specialist

2 days ago


Manassas, Virginia, United States Granules Full time
Job Description

As a Senior QA Associate, Compliance/QA Lead at Granules Consumer Health, you will play a crucial role in ensuring product compliance to established cGMPs, meeting safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs).

Key Responsibilities:

  • Conduct assessments of cGMP Compliance gaps and implement plans for gap closure.
  • Support Serialization and aggregation process implementation as per the Drug Supply Chain Security Act (DSCSA).
  • Interpret and discuss key Quality metrics data to recommend changes required to sustain Quality and safety of manufactured products.
  • Review and release of batches, participation in qualification of utilities, systems, and equipment on-site.
  • Support training programs to ensure competency of personnel engaged in cGMP activities.
  • Support all aspects of investigations, including out-of-specification and manufacturing investigations.

Requirements:

  • Bachelor's/master's in chemistry or related scientific field.
  • Minimum 5+ years hands-on Quality Assurance experience in Pharmaceutical Industry.
  • Experience in OSD Pharmaceutical Packaging Operations required.
  • Hands-on experience in implementation of Serialization and aggregation process highly preferred.
  • Knowledge of Good Manufacturing Practices (cGMP).

Physical Requirements/Working Environment:

  • Laboratory environment with lab coats and safety glasses.
  • 8 hours per day.
  • 6-8 hours standing while performing the task.
  • Must be able to lift 50lbs.


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