Granules Pharmaceuticals, Inc.
Senior QA Associate/QA Lead, Compliance (OSD Pharma Experience Required)
Granules Pharmaceuticals, Inc., Manassas, Virginia, United States, 22110
Senior QA Associate/QA Lead, Compliance (OSD Pharma Experience Required)
Full-time position located in Manassas, VA focused on identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) to comply with FDA regulations; support Serialization and aggregation process implementation for Granules Consumer Health; collaborate with QA Manager, Operations, Warehouse, and Supply Chain to drive compliance and right first-time practices.
Through direct participation and contribution towards improvement of site Compliance, you will develop hands-on experience working in a Pharma Packaging site to promote safety and quality of our products.
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). Tasks may vary by product and packaging activities based on scope, sequence, complexity, and timing. Individuals will be trained and will have an opportunity to apply knowledge of science and prior experience in cGMP operations to execute and deliver results through improvement in Compliance at the Manassas site.
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 trend 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 troubleshooting 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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Through direct participation and contribution towards improvement of site Compliance, you will develop hands-on experience working in a Pharma Packaging site to promote safety and quality of our products.
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). Tasks may vary by product and packaging activities based on scope, sequence, complexity, and timing. Individuals will be trained and will have an opportunity to apply knowledge of science and prior experience in cGMP operations to execute and deliver results through improvement in Compliance at the Manassas site.
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 trend 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 troubleshooting 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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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