Quality Assurance Associate - Newark, New Jersey | CareerCircle
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Quality Assurance Associate



Posting ID: JP-002663383

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Newark, New Jersey
Full Time
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Support QA Manager in cGMP manufacturing and laboratory operations through monitoring and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.

Responsible for tracking and trending QMS metrics including, but not limited to, those related to training, deviations, CAPA, Change Controls, OOS, and internal/external audits performance.

Support the maintenance of Quality Management System by serving as supportive system administrator supporting workflow facilitation, document migration, and configuration management

Coordinate instructor-led training, computer-based training, and team learning.

Support QA Manager in implementing vendor/supplier quality program through review and reporting of vendor change notifications, part number requests, raw material specifications, and raw material release.

Assist in internal audits and in external vendor/supplier audits against applicable quality system standards and regulations.

Support the implementation, continuous improvement, and oversight of Quality Management System procedures and associated training material.

Job Requirements

Bachelor’s Degree in Life Sciences or Engineering

At least 2 years of relevant GMP experience in biotech company or CDMO, with broad knowledge of current Good Manufacturing Practices, Quality Systems and Analytical Method development and validation

Understanding of cGMP/ICH/FDA regulations and guidelines

Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)

Experience in developing, reviewing and approving cGMP related documents (SOPs, protocols, reports, etc.)

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.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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