Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• QA Specialist II

Description:

Assures the quality of manufactured products and processes per-standard operating processes (SOP'S) and GMP (Good Manufacturing Practices).

Purpose:
The QA Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System. This includes support on policy &procedure, program management, patient record review, internal/external audit, and metrics and trend analysis and reporting.

Responsibilities:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Provides effective quality controls to the referral management, call center and fulfillment operations.
• Monitors compliance with all policies and procedures in addition to all federal/state/local governmental and pharmacy laws and regulations.
• Develops QA training programs and materials and provides training to departmental personnel.
• Evaluates, analyzes, and trends quality indicators, data, performance metrics and prepares daily/monthly reports of pharmacy solutions quality measurements.
• Manage QA lists, spreadsheets, and databases as required to support the business
• Participates in Quality Improvement initiatives and assures customer satisfaction.
• Conducts investigations and provides timely resolutions to variance, incident, exception issues.
• Participates in the development and implementation of permanent corrective actions.
• Prepares ad hoc quality and other reports as requested by management and external customers.
• Conduct internal audits on the business functions of Pharmacy Solutions and Supports external audit logistics and operations.

Qualifications:

• BS in a scientific discipline or related experience.
• Minimum of 2 years’ experience in a Quality related field.
• Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint).
• Good oral, written, and presentation skills.
• Sound decision making and problems solving skills to assure business unit compliance.
• Strong analytical skills, ability to analyze data and trends and draw conclusions.
• Good mathematics background with an understanding of basic statistical concepts.