The contract position performs specific duties within the area of commercial Quality Management System. The role performs quality review of API and finished product batch records, coordinates product complaint investigations, review vendor Deviations/CAPA, manage process change controls, and gather data to support Annual Product Review (APR) reports. Other responsibilities may be added as the organization expands. This position will be hybrid and located out of the Chicago area.
Responsibilities:
Prior experience with processing "drug" product complaint investigations
Responsible for Batch Record Review and release of API and/or Finished Product
Review vendor Deviations and Corrective Actions for adequacy
Manages change controls for commercial product
Prepares and reviews Annual Product Review reports.
Partners with multiple functional areas along with senior leadership
Work will be performed under the direction of quality leadership with a majority of the job duties performed independently with routine updates to leadership
Required Qualifications:
Bachelor's degree or equivalent experience within an FDA regulated company require
Minimum of 4 years of experience in an FDA regulated company
Experience working within electronic quality systems, preferably in support of system validation/qualification
Prefer experience with product complaints, investigations, and/or CAPA within the pharmaceutical or medical device industry
Excellent interpersonal, verbal, and written communication skills - ability to speak to all levels of internal stakeholder
Demonstrated ability to execute multiple critical projects/issues simultaneously
Experience with GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), and GCP (Good Clinical Practices) regulations
If you meet the required qualifications and are interested in this role, please apply today.
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.