Manufacturing Quality Assurance Technician

Manufacturing Quality Assurance Technician

Job Locations US-GA-Norcross

Job ID

2024-3586

Category

Quality

Overview

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant.

Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials.

We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

We are seeking an experienced Manufacturing Quality Assurance (MQA) Technician to join our team. Our company is a growing medical technology firm that offers challenging positions, opportunities for professional growth, and competitive benefit packages to all employees.

As a Manufacturing Quality Assurance Technician, you will be responsible for ensuring the compliance of Werfen manufacturing process through auditing, sampling and inspection of the in-process laboratory / manufacturing / packaging / warehouse areas in addition to inspections of incoming and finished goods.

You will make real-time quality decisions including determination of a deviation, product hold, stopping operations, segregation of nonconforming product / components, etc.

based on findings of specific events that could affect product quality.

If you have the necessary skills and experience to excel in this position, we want to hear from you!

This position is not eligible for sponsorship for work authorization . Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .

Manufacturing Quality Assurance Technician - Quality Auditor (Laboratory / Biomedical Manufacturing Technician)

Responsibilities

Key Accountabilities :

Perform inspection and testing of incoming components, in process product and finished product in the manufacturing areas and / or warehouse locations to ensure compliance with established specifications and department defined timeframes.

• Perform duties for the receiving, sampling, issuance and inventory of raw materials, components and product according to departmental procedures.
• Initiate or assure initiation of product holds and / or deviations per applicable procedures or as directed by management.

Assist in the investigation of such occurrences, as needed

• Perform product releases to Finished Goods both physically and electronically according to departmental procedures, as needed.
• Document all results accurately per applicable procedures in alignment with GDP.
• Follow applicable laboratory OSHA regulations with respect to chemical hazards, blood-borne pathogens, etc and understand FDA and ISO standards applicable to the department.
• Assist management team with projects and / or special assignments as requested to ensure Company / departmental deadlines and daily tasks are met.
• Comply with all applicable policies and requirements described in the Employee Handbook and Code of Ethics Perform daily QA operations in compliance with SOPs and cGMPs.

Conduct business in a polite, helpful and professional manner with all internal and external customers.

Maintain knowledge of and ensure compliance to company's SOPs related to their job

Additional responsibilities include :

• Stay abreast of industry Best Practices and participate in process improvement initiatives to keep Werfen in alignment with cGMPs.
• The MQA Technician may be asked to support the following areas requiring experience or training in any or a combination of :
• Laboratory (Quality Control, Serums, Micro, Red Blood Cells (RBC)
• Aseptic Filling / Vialing
• Material receipt - Incoming inspection
• Solid Phase Manufacturing
• Red Cell Manufacturing
• Monoclonal Manufacturing
• Liquid Reagent Manufacturing
• Incoming inspections of artwork
• AQL inspections of product

Manufacturing Quality Assurance Technician - Quality Auditor (Laboratory / Biomedical Manufacturing Technician)

Qualifications

Minimum Knowledge & Experience required for the position :

Associate' Degree (AA) or equivalent from a two-year college or technical school; or six months to one year related experience and / or training;

or equivalent combination of education and experience.

Ability to work independently and in a fast-paced, team-oriented environment

Must be detail-oriented and able to multi-task

Stay abreast of industry best practices and recommend, and / or participate in process improvement initiatives to keep Werfen in alignment with cGMPs

Incoming inspections

Manufacturing Quality Assurance Technician - Quality Auditor (Laboratory / Biomedical Manufacturing Technician)

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