Quality Assurance Specialist
PURPOSE & SCOPE
The Quality Assurance Specialist provides technical and advanced support to the Quality Manager and the Operations Department.
ESSENTIAL JOB FUNCTIONS
Assist in the continuous maintenance and improvement of quality systems and practices through reviews of established systems for cGMP compliance. Assists in performing and coordinating Document Control activities; reviews and evaluates SOPs, protocols, and other related documents for quality assurance and cGMP compliance.
Assists employees in writing effective justifications for document, product, and process changes.
Reviews cGMP related documents (i.e. analytical/manufacturing records, stability, protocols, reports, etc.) pertaining to chemical intermediates and APIs for accuracy, completeness, and compliance with policies, procedures and cGMP.
Monitor trends and analyze raw data from QC reports, batch records, and contractor’s lab reports.
Identifies and documents procedural deviations and discrepancies through auditing, record reviewing, and multi-departmental interactions. Proposes corrective actions and verifies effective implementation.
Trends quality data such as deviation, process changes, and control data. Communicates potential compliance issues to management in a timely and effective manner. Coordinates change control activities, including development of change control forms and documented changes, managing change control, assuring proper revision control.
Assists management during FDA inspections. Interprets direction of the inspection and reacts accordingly and quickly to mitigate potential problems. Supports the timely and accurate transfer of data, documents, and information to inspectors. Assures that routine maintenance activates such as environmental monitoring, temperature monitoring, facility cleaning and other process control activities are performed as required by policies and procedures.
Direct contact with equipment manufacturers, suppliers, and service providers on an as needed basis.
Completes Batch Record Review and Product Release activities.
Assists with annual Mock Recall activities.
Coordinates and maintains stability program activities. Prepares stability program C of A’s and summary reports.
Other duties as assigned.
Associates Degree in a scientific discipline or the equivalent combination of education and experience required.
At least 1 year of previous experience in a GMP and GLP environment.
Proficiency with Microsoft Office (Excel, Word, Access, PowerPoint, and Vision software required.
Knowledge of pharmaceutical cGMP, FDA guidelines and industry standards.
Must be well organized.
Ability to work effectively in a team.
Strong technical writing skills.
Multitasking and attention to detail.
Must be able to work independently.
Ability to handle confidential company data, projects, information, etc.