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:

• Associate Quality Analyst II

Purpose:
The Quality Analyst is responsible for resolution of issues with suppliers (investigations and
corrective actions), maintenance of supplier status, evaluation and closure of supplier change
notifications, supplier scorecards and SQA reports.

Responsibilities:

• Coordinates resolution of problem relating to quality and performance of purchased materials with suppliers and Manufacturing Quality Assurance.
• The incumbent monitors and manages implementation of new and existing processes that ultimately impact vendor product quality assurance.
• Establish and document contact with suppliers concerning quality issues/concerns (i.e. nonconformity, deviation, defect report, waivers, etc.).
• Perform assessment of supplier change notification (SCN) of incoming material. Monitor supplier change notification review through Plant (as applicable) to ensure a timely completion.
• Evaluates the plant Specification Acceptance Letter exception and assess need for elevation to area management, as needed.
• Updates and maintains the System Application Product (SAP) system with current specification
• date, approval of supplier sites and/or purchasing control.
• Interfaces with and maintains cooperative relationships with plant and departments to assure the total integrity and usability of incoming materials.
• Assists section with the follow-up and close out of the management reviews action items upon their implementation.
• Ensures that all quality goals are met, and all practices and procedures comply with the policies and applicable regulations for the Quality areas under his/her responsibility.

Qualifications:

• Bachelor's degree in Natural Sciences, Biology, Chemistry or Engineering.
• Technical Skills:
• Good verbal and written communication.
• Good problem solving and analytical skills.
• Good interpersonal relations/communications skills.
• Good negotiation skills.
• Good analytical skills.
• Quality related work in the pharmaceutical or medical device Health Care Organization.
• Total combined minimum years of experience required - 2 years.
• Key Stakeholders: Suppliers, Purchasing, IQA, Materials Management, TPM's, Technical groups, Manufacturing, Quality Assurance, Compliance, Validation, etc.