Quality Analyst

Description

Monday to Friday 8-430

The supplier is responsible for determining if this is Exempt/ Non Exempt.

The supplier needs to indicate when submitting the worker if they are exempt or not exempt

Purpose:

• Describes the primary goals, objective or function or outputs of this position.
• 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 :

• List up to 10 main responsibilities for the job.
• Include information about the accountability and scope.
• 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 and Client (as applicable) to ensure a timely completion.
• Evaluates Client Specification Acceptance Letter exception and assess need for elevation to area management, as needed.
• Updates and maintains the System Application Product system with current specification date, approval of supplier sites and/or purchasing control.
• Interfaces with and maintains cooperative relationships with plant and Client departments to assure the total integrity and usability of incoming materials.
• Serves as an effective liaison and maintains a cooperative relationship with other Quality areas, Plant departments, Client North Chicago, Client Bioresearch Center counterparts, and TPMs as needed.
• 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 Client policies and applicable regulations for the Quality areas under his/her responsibility.

Qualifications :

List required and preferred qualifications up to 10).

• Include education, skills and experience.
• Bachelor 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.
• 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.
• Good problem solving and analytical skills
• Good interpersonal relations/communications skills
• Good verbal and written communication
• Good negotiation skills
• Quality related work in the pharmaceutical or medical device Health Care Organization. Total combined minimum years of experience required - 5 years.
• Supplier Management Experience