Senior Quality Assurance Specialist
3 days ago
We are seeking a Senior QA Associate, Compliance/QA Lead to join our team at Granules Consumer Health. This is an exciting opportunity for a highly motivated and experienced individual to lead the compliance efforts in our operations at Manassas, VA.
As a Senior QA Associate, Compliance/QA Lead, you will 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.
Key Responsibilities
- 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.
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