Quality Assurance Manager

9 hours ago


Glen Burnie, Maryland, United States BioSpace, Inc. Full time
Job Opportunity

The Assistant Manager Quality (AMQ) reports to the Associate Director Quality. This position is located on site at our center in Glen Burnie, MD.

The Role
  • Ensure the center is "inspection ready" by managing adherence to Standard Operating Procedures (SOPs), compliance policies, and the quality system.
  • Manage the Quality Control program, calibrations management, monitoring of compliance to defined processes, e.g., sampling, competency checks, trending, and analysis of KPIs, cause and failure mode impact assessment, and change management.
  • You will recruit, hire, conduct performance reviews, lead investigations and deviations, enact corrective actions, and termination.
  • Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA), federal, state, and local regulatory, company policies, and procedures.
  • Follow all HR policies and practices through fair treatment of all employees.
  • Monitor CAPA's and effectiveness checks to ensure issues are resolved.
  • Overnight travel required up to 10% of the time.
Your Skills and Experience

Education

Bachelor's Degree preferred or equivalent combination of education and professional work experience required.

Experience
  • 1 year supervisory, leadership experience responsible for overseeing the activities of others or completion of CSL Plasma Leadership Development program.
  • 1 year Quality experience (CSA/CSAb) required.
Additional Comments
  • Maintain company Technical Training certification.
  • Knowledge of complex government and industry regulations and ability to monitor compliance with these regulations.
  • Manage entire financial responsibility of the center.
  • Proficient in English.
Working Conditions
  • Exposure to hazardous chemicals, extreme temperatures, and to bloodborne pathogens.
  • Required to wear Personal Protective Equipment while performing tasks or in certain areas.


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