QA Specialist

Quality Assurance · Frederick, Maryland
Department Quality Assurance
Employment Type Full-Time
Minimum Experience Mid-level

Summary of the Position: 


 


QA Specialist’s primary responsibility is the review and audit of internal batch records, GLP and GMP studies, and SOPs as well as to manage the equipment including coordinating and overseeing IQ/OQ/PQ. The specialist anticipates and solves problems and issues within his/her area of responsibility. In addition, the specialists helps to design, develop and implement new tools and techniques used in the overall Quality and Equipment Management Systems. 


 


Roles and Responsibilities:


• Audits study data and reports 


• Participates in Quality Management Systems programs, including investigations, CAPAs, Deviations, and Laboratory Investigations


• Participates in accreditation activities identified by management


• Conducts Internal Process/Target audits according to schedule


• Participates effectively in cross-functional teams to maintain and improve the quality metrics


• Provides training in Quality concepts and tools, and design/develop training materials and instructional materials


• Is responsible for equipment management including connecting with vendors and staff for calibration, IQ/OQ/PQ, and temperature mapping studies


• Performs other related duties as required


 


 


 


Basic Qualifications


• Bachelor’s degree in in Biology, Biotechnology or related discipline required or equivalent work experience


• Minimum of three (3) years of relevant Quality Control (QC) or QA experience in a pharmaceutical, biotech or other regulated industry


Preferred Qualifications


• Good understanding of GLP and GMP regulations


• Previous auditor training is preferable - demonstrated skill in audit planning and auditing techniques is desirable


• Well organized and able to work independently 


• Demonstrated verbal and written communication 


• Ability to explain complex information clearly to a diverse audience


• Effective in a variety of formal and informal settings; one-on-one, small and large groups with peers and senior management


• Individual must possess the ability to work well with diverse cultures and to influence without direct authority


 

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  • Location
    Frederick, Maryland
  • Department
    Quality Assurance
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level