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Actalent QA Specialist in Cambridge, Massachusetts

Description:

Department Description:

The Quality Assurance department ensures that the site operates at a high level of compliance and ensures quality decisions are being made in accordance with regulatory and site requirements.

Position Summary:

This position is responsible for operational support, including batch record review, media disposition, label issuance and reconciliation, archiving, final product packaging/release to the courier, customer complaint audits, write and/or revise standard operating procedures

Core Responsibilities:

Master core responsibilities of Specialist I.

Maintaining and adhering to compliance requirements for established quality systems programs.

Identify issues, provide recommendations as well as executing compliance improvements.

Participate in mid-scale projects or assignments.

Address and/or escalate compliance problems and issues.

Interact with project teams and applicable research groups as they impact the quality operation.

Product complaints: independently receive, review, audit accompanying patient file, and send to Customer Care.

Independently initiate QA deviations and perform investigations, including determining root cause and planning corrective actions.

Support the training of specialist I’s.

Other duties as assigned.

Skills:

qa, quality assurance, batch record, batch record review, deviation, capa, investigations, document control, documentation review, Gmp, biologics, medical device, pharmaceutical

Top Skills Details:

qa,quality assurance,batch record,batch record review,deviation,capa,investigations,document control,documentation review

Additional Skills & Qualifications:

Leadership Qualifications:

An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:

Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.

Being honest and treating people with respect and courtesy.

Constantly striving to make our client a great place to work, and a company respected for the quality of its people and products.

Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

Basic Qualifications:

High School Diploma plus 3+ years of related experience in Quality Assurance.

Basic knowledge of GMP regulations

Preferred Qualifications:

Strong written and verbal communication skills

Strong organization and time management skills

Experience with Electronic Quality Management Systems (Trackwise)

Proficient in MS Word, Excel, and PowerPoint

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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