Quality Assurance Specialist (pharma)

Insight Global; Durham (NC); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Insight Global is seeking a QA Specialist in Durham, NC to perform compliance reviews of manufacturing documentation and support GMP release of bulk drug substance. You will review batch records, coordinate issue resolution, and support deviations and CAPAs, collaborating with manufacturing, lab, and QA teams.

Direct client communication on documentation issues is also included. The role focuses on ensuring cGMP compliance across US, EU, and RoW guidelines, with emphasis on timely batch

Qualifications

• Bachelor’s Degree with 6+ years of relevant experience, or a Master’s Degree with 4+ years of relevant experience.
• Quality Assurance experience within a cGMP-regulated biopharmaceutical environment or an equivalent regulated setting.
• Experience reviewing batch records within a regulated manufacturing environment.
• Experience supporting quality investigations and CAPAs.
• Working knowledge of Quality Systems supporting GMP manufacturing and batch disposition.
• Knowledge of United States, European Union, and Rest of World cGMP guidelines.

Responsabilités

• Perform detailed compliance reviews of master batch records, executed batch records, internal support records, and applicable logbooks.
• Support conditional and final GMP release activities associated with the disposition of bulk drug substance.
• Review internal and client documentation for accuracy, completeness, and compliance with applicable cGMP requirements.
• Partner with manufacturing and other internal departments to resolve client comments within required batch release timelines.
• Communicate directly with clients to address documentation issues and questions affecting batch disposition.
• Work with manufacturing, laboratory, and other GMP functions to resolve deviations and compliance concerns.
• Support investigations and CAPA activities related to manufacturing records, quality events, and batch release.
• Assist management with the development and reporting of batch record review metrics.
• Participate in process improvement initiatives focused on reducing batch record review cycle times and improving batch release dates.
• Attend operational meetings supporting QA batch record review and disposition activities.
• Adapt to changing priorities and complete additional quality-related responsibilities as assigned.

Connaissances

QA experience

cGMP knowledge

Batch records review

CAPA investigations

Quality systems

GMP guidelines knowledge

Formation

Bachelor’s degree with 6+ years

Master’s degree with 4+ years

Description du poste

• Bachelor’s Degree with 6+ years of relevant experience, or a Master’s Degree with 4+ years of relevant experience.
• Quality Assurance experience within a cGMP-regulated biopharmaceutical environment or an equivalent regulated setting.
• Experience reviewing batch records within a regulated manufacturing environment.
• Experience supporting quality investigations and CAPAs.
• Working knowledge of Quality Systems supporting GMP manufacturing and batch disposition.
• Knowledge of United States, European Union, and Rest of World cGMP guidelines.

Job Description:

The QA Specialist will perform compliance reviews of manufacturing documentation and support the conditional and final GMP release of bulk drug substance. This position will review internal and client batch records, coordinate the resolution of documentation issues, and support deviations and Corrective and Preventive Actions, or CAPAs. The specialist will work closely with manufacturing, laboratory, Quality Assurance, and other GMP-supporting departments. The role also involves direct client communication related to batch record comments, compliance issues, and batch disposition.

Key Responsibilities:

• Perform detailed compliance reviews of master batch records, executed batch records, internal support records, and applicable logbooks.
• Support conditional and final GMP release activities associated with the disposition of bulk drug substance.
• Review internal and client documentation for accuracy, completeness, and compliance with applicable cGMP requirements.
• Partner with manufacturing and other internal departments to resolve client comments within required batch release timelines.
• Communicate directly with clients to address documentation issues and questions affecting batch disposition.
• Work with manufacturing, laboratory, and other GMP functions to resolve deviations and compliance concerns.
• Support investigations and CAPA activities related to manufacturing records, quality events, and batch release.
• Assist management with the development and reporting of batch record review metrics.
• Participate in process improvement initiatives focused on reducing batch record review cycle times and improving batch release dates.
• Attend operational meetings supporting QA batch record review and disposition activities.
• Adapt to changing priorities and complete additional quality-related responsibilities as assigned.