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Senior QA Associate/QA Lead, Compliance

5 months ago

Manassas, United States Granules Full time
Job DescriptionJob DescriptionDescription:

The Senior QA Associate, Compliance/QA Lead will be responsible for identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) related activities to comply with FDA regulations, support Serialization and aggregation process implementation for Granules Consumer Health. You will work closely under the guidance of Quality Assurance (QA) Manager, and interact with Operations, Warehouse, and Supply Chain professionals to drive compliance and right first-time practices in our operations at Manassas, VA.


Through direct participation and contribution towards improvement of site Compliance, you will develop hands on experience working in a Pharma Packaging site to help promote safety and quality of our products.


As a Senior QA Associate, Compliance/QA Lead, you would be responsible for ensuring product compliance to established cGMPs, to meet safety and quality standards for FDA Regulatory and customer requirements by adherence to Standard Operating Procedures (SOPs). Based on products and packaging activities the tasks assigned may vary in scope, sequence, complexity, and timing. Individuals will be trained and will have an opportunity to apply their knowledge of science and prior experience in cGMP operations to execute and deliver results through improvement in Compliance at the Manassas site.



Responsibilities include but not limited to:

  • Conduct assessment of cGMP Compliance gaps.
  • Support Serialization and aggregation process implementation as per the Drug Supply Chain Security Act (DSCSA).
  • Implement plans for gap closure and follow up on the corrective actions to ensure sustainable cGMP Compliance.
  • Interpret, discuss and trends in key Quality metrics data to recommend changes required to sustain Quality and safety of manufactured products.
  • Review and release of the 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.
  • Perform routine trouble shooting of cGMP excursions including determination of root cause analysis.
  • Assist other analyses of data, and interpretation.
  • Maintain and update key Quality metrics for assessment of cGMP at the Manassas site.
  • Identify and communicate continuous improvement opportunities to the Quality Assurance Manager.
  • Responsible for the safe and efficient execution of job duties and abiding by established quality standards.
  • Exposure to enhance skills to develop a better understanding of applying and interpreting FDA regulations to medicinal drug products.
  • Improve the site compliance through implementation of corrective actions to close identified cGMP gaps.


Requirements:

Minimum Experience & Education Required

  • Bachelors/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).

Required Knowledge/ Skills

  • Proven knowledge of cGMP procedures and processes.
  • Hands on experience in implementation of Serialization and aggregation process.
  • Proficient in documentation as per Good Documentation Practice.
  • Troubleshooting abilities.
  • Computer skills including Microsoft and Excel.
  • Excellent verbal and written communication skills

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.