QA Specialist II

Weil Group•Barceloneta, PR

About The Position

We are seeking a professional qualified to assure the quality of manufactured products and processes per standard operating processes (SOP'S) and GMP (Good Manufacturing Practices). Alternative job title: Supplier Quality Analyst. 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.

Requirements

Bachelor's degree in Natural Sciences, Biology, Chemistry or Engineering.
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.

Nice To Haves

experience in pharmaceutical industry
preference experience in incoming quality area
preference experience in supplier quality area
bilingual
Total combined minimum years of experience required - 5 years.

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 AbbVie (as applicable) to ensure a timely completion.
Evaluates AbbVie 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 AbbVie 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, AbbVie North Chicago, AbbVie 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 AbbVie policies and applicable regulations for the Quality areas under his/her responsibility.
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.