Supplier Quality Analyst

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We’re seeking a Supplier Quality Analyst to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it’s all about finding the job that’s just right

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 and Customer (as applicable) to ensure a timely completion.

Evaluates Customer 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 Customer 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, Customer North Chicago, Customer 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 Customer

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.

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.