Quality Compliance Associate - Buffalo Grove, United States - Clinical Resource Network (CRN)

Clinical Resource Network (CRN) Buffalo Grove, United States

2 weeks ago

Human Resources

Description

The contract position involves specific responsibilities within the commercial Quality Management System area. The role includes conducting quality reviews of API and finished product batch records, coordinating product complaint investigations, reviewing vendor Deviations/CAPA, managing process change controls, and collecting data to support Annual Product Review (APR) reports. Additional duties may be assigned as the organization grows. The job, which will be located near Chicago, will have a hybrid working model.

Key Responsibilities:

Prior experience in handling product complaint investigations
Responsible for Batch Record Review and release of API and/or Finished Product
Reviewing vendor Deviations and Corrective Actions for adequacy
Managing change controls for commercial product
Preparing and reviewing Annual Product Review reports
Collaborating with various functional areas and senior leadership
Working under the guidance of quality leadership, with most tasks performed independently and regular updates provided to leadership

Minimum Requirements:

Bachelor's degree or equivalent experience in an FDA regulated company
Minimum of 4 years of experience in an FDA regulated environment
Experience with electronic quality systems, especially in system validation/qualification support
Preferably, experience in product complaints, investigations, and/or CAPA in the pharmaceutical or medical device industry
Strong interpersonal, verbal, and written communication skills - ability to engage with stakeholders at all levels internally
Demonstrated capability to manage multiple critical projects simultaneously
Familiarity with GMP, GDP, and GCP regulations

If you meet the criteria and find this opportunity appealing, we encourage you to submit your application without delay.

Clinical Resource Network Highlights

CRN, a branch of Solomon Page, provides a comprehensive benefits package for hourly employees, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits. Our commitment to offering these benefits, even to consultants, distinguishes us within the industries we operate in.

About CRN

Established in 2002, Clinical Resource Network (CRN) delivers clinical research and talent solutions to pharmaceutical, biotech, and medical device firms. Emphasizing long-term partnerships, our services cover contract staffing, project staffing, consultative services, and permanent placements. For further details, visit our website and connect with us on social media platforms.

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