Oncology Quality Manufacturing Manager

Company: Beacon Hill Staffing Group
Location: Lake Forest
Posted on: May 16, 2022

Job Description:

MUST HAVE BATCH RELEASE EXPERIENCEMUST BE ABLE TO WORK TWO DAYS ONSITE AND REMOTE- HYBRID MODEL
Quality Assurance Manager
This position primarily functions as the front-line of Quality Assurance. Principal responsibilities include quality activities (NMR, CAPA, Change Control), tracking of all training records, document control and release, Supply Chain and providing support to Regulatory Affairs. --- Release products for commercial distribution.--- Review and approve validation protocols and reports.--- Develop and maintain SOP's.--- Quality review of batch records, analytical data, manufacturing/packaging deviations and investigations.--- Issue and control of Certificates of Analysis.--- Document Control/Quality System maintenance and support.--- Manage the technology transfer process with pharmaceutical intermediates and contract manufacturing organizations.--- Responsible for Change Control, NMR, CAPA, SCAR databases and trending.--- Update and maintain vendor qualification databases.--- Assist with Annual Product Reviews, Management Reviews, and Annual Product Report preparation.--- Process complaints and assist with MDR and pharmacovigilance activities.--- Participate in internal and external audits.--- Update and maintain employee training database.--- FDA audit experience.

Qualifications, education, and experience: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and education required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. B.S. preferred with 3+ years hands on quality assurance experience in the pharmaceutical or, biotechnology industry. General knowledge of drug and device quality regulations including parts 820, 210, and 211 of Title 21 of the CFR. Knowledge of ISO standards 13485, 14971 and ICH regulatory standards. Thorough understanding of sterile manufacturing processes and operations. Strong technical, interpersonal, problem-solving and decision-making skills organizational, verbal and written communication skills. Skill and ability to organize file systems.

Keywords: Beacon Hill Staffing Group, Chicago , Oncology Quality Manufacturing Manager, Professions , Lake Forest, Illinois