Senior Quality Assurance Specialist

Responsible for batch record review and disposition of API and Drug Product lots with reference to approved specifications.

Review, revise and maintain standard operational procedures (SOP) and specifications.

Review for administration of deviations, out of specification (OOS), and out of trend (OOT) events and participate in preparation of reports.

Create and administer change control records and follows up on completion of changes.

Participate in risk assessment and gap assessment as it relates to maintaining compliance with safety, quality and regulatory standards.

Facilitate employee training on current SOPs according to GxP requirements and archives training records.

Experienced in MasterControl Quality Management System, especially as a system administrator.

Experienced in making independent decisions related to controlled document management.

Responsible for GxP controlled document management and archiving.

Responsible for attaining and archiving of relevant records from CMOs and Contract labs.

Perform activities to maintain and improve quality systems.

Other responsibilities include supporting manufacturing, clinical operations, and supply chain departments as necessary.

REQUIREMENTS

Knowledge of GMP rules and regulations and ICH guidelines

Bachelor's or Master's degree in chemistry or one of the life science disciplines

Minimum 5 years' experience Quality Assurance of Pharmaceutical/ biotech industries

Knowledge and experience with MasterControl as a system administrator with special focus on quality systems, document management, and training modules

Proficient in Word, Excel, and PowerPoint

Strong verbal and written communications skills

A team player