Assistant Director, Quality Control Testing - Wake Forest Institute for Regenerative Medicine – Full-time, Staff
Under the directive of the RMCC Director, the Assistant Director of QC is responsible for laboratory testing of raw materials, in-process samples, final products, process developmental products, qualification studies and stability studies to ensure product safety, efficacy, and identity. The position requires planning, organizing, scheduling, and directing the department in order to effectively utilize employees and equipment to meet established turnaround time and material utilization within budgetary constraints while adhering to quality technical standards.
The Assistant Director provides direct day to day operation including adjustment of specimen workflow, test performance, quality, compliance, and associated documentation to adhere to the applicable regulatory agencies, company policies and procedures. Provides testing support of project related activities for manufacture of clinical products and/or process developmental products to ensure product safety, efficacy, and identity. Performs a variety of moderately complex and generally standardized physical, chemical and/or biological operations using validated equipment and procedures.
Oral and/or written instructions received from Director.
Skills and Qualifications:
Excellent recordkeeping and documentation skills
Ability to develop and implement quality processes and metrics
Ability to evaluate quality processes and recommend improvements
Experience with documentation and technical writing in a regulated compliance environment.
Strong communication skills, both verbal and written
Understanding of Microsoft Excel, Word and other computer software
Outstanding interpersonal skills, high energy and motivated
Supervisory experience required and management experience preferred
Oversees, develops, implements and/or maintains quality control systems and activities.
Oversees, develops, implements and/or follows standards, methods and procedures for inspecting, testing and evaluating the identity, safety, efficacy and reproducibility of products.
Supervises routine and non-routine analysis of consumables/reagents, in-process and finished products according to SOPs.
Oversees the operation of various analytical equipment and data collection software such as Flow Cytometers, Microscopes, BacT/ALERT 3D Sterility, Mycoplasma and Endotoxin testing.
Writes and/or executes process and equipment validation documents.
Oversees the performance of environmental monitoring activities to help maintain regulatory requirements for microbial and particulate counts in the GMP facility.
Assures that products, processes, facilities and systems conform to quality control standards and GMP regulations.
Writes and/or revises SOPs to support internal quality control systems, data systems, technical issues and instrumentation.
Passes stringent GMP gowning and aseptic processing qualifications to attain/verify skill level consistent with working in a GMP environment.
Selects all requisite GMP QC Laboratory consumables and reagents.
Maintains the controlled environment of the GMP QC Laboratory by overseeing the maintenance, cleaning and/or qualification of laboratory equipment.
Trains QCT personnel on all equipment functions and laboratory processes.
Oversees troubleshooting and/or troubleshoots all equipment and laboratory processes with minimum support.
Oversees laboratory investigations for all product which does not confirm to specifications and notifies affected departments.
Takes initiative to identify opportunities for process improvement and implementation.
The Regenerative Medicine Clinical Center (RMCC) is constructed to enable the production of tissue engineered products for evaluation in Phase I/II clinical studies in compliance with the current good manufacturing practice regulations (cGMP) as well as the other applicable regulations for biological products and human cells, tissues, and cell and tissue based products.
The RMCC consists of ISO 7 and ISO 8 classified cleanroom space along with an external Quality Control Laboratory and Warehouse. Access to all classified areas requires appropriate gowning and aseptic techniques.
Education / Experience:
Graduate degree with a major in life sciences or biology, chemistry, Biomedical engineering or other science related discipline and three years of related quality control and/or quality assurance experience; OR
Graduation from a four-year college or university with a major in life sciences or biology, chemistry, Biomedical engineering or other science related discipline and five years of related Quality Control.
Previous supervisory or management experience preferred.
Internal Number: 29532
About Wake Forest Baptist Medical Center
Wake Forest Baptist Medical Center (www.wakehealth.edu) is a nationally prominent academic medical center in Winston-Salem, North Carolina, with an integrated health care network that serves the residents of 24 counties in northwest North Carolina and southwest Virginia. The Medical Center’s primary divisions are Wake Forest Baptist Health, a regional clinical system anchored by the 885-bed tertiary care hospital in Winston-Salem that includes Brenner Children’s Hospital, five other hospitals throughout the region, more than 300 other primary and specialty care locations, more than 2,000 physicians and 1,535 acute care beds; Wake Forest School of Medicine, a recognized leader in experiential medical education and groundbreaking research; and Wake Forest Innovations, the school’s commercialization enterprise focused on advancing health care. Wake Forest Baptist clinical, research and educational programs are consistently rated among the best in the country by U.S. News & World Report.