Associate Quality Assurance Specialist Testing

Overview

The Associate Quality Assurance Specialist Testing reviews Testing batch records in accordance with current Good Manufacturing Practices (cGMP).  Monitors processes for adherence to established procedures/regulatory compliance.  Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner. 

Responsibilities

• Compiles and reviews manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner. Assures that any observations/deviations are properly investigated and explained.
• Compiles and reviews raw data and batch records in accordance with cGMP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner.  Assure that any observations/deviations are properly investigated and explained.
• Maintains awareness of activities by routine direct observation of Cell Production suites and facility.  Interact frequently with laboratory/operations/facility staff to provide quality perspective on routine operations and support system.  Address conditions/practices with appropriate personnel, documents and reports findings to Management.
• Writes and revises SOPs as necessary.
• Reviews and approves document change requests.
• Verifies and releases shipments of finished product or cell bank vials to clients or contract labs.
• Performs QA inspections including, but not limited to: filled vials, packaging, changeover and line clearances.
• Participates in label preparation and inspection for cell bank and cell therapy processes.
• Participates in quality and process improvement initiatives and project teams.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.)
• Performs other duties as required. 

Qualifications

• BA/BS degree in a Science related major
• 1 experience required
• Knowledge of cGMP requirements, PTC guidelines and ISO17025 is highly desirable.
• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, and Access).
• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations. 
• Ability to record data accurately and legibly.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled