Quality Assurance Specialist
COMPANY: Champions Oncology, Inc.
TITLE AND CLASSIFICATION: Quality Assurance Specialist / Exempt
REPORTING LOCATION: Rockville, MD
REPORTS TO: Quality Assurance Manager, Compliance and Training
PRIMARY OBJECTIVES: Assist with tasks to meet regulatory requirements and company policies.
DUTIES AND RESPONSIBILITIES
- Quality Assurance and Process Improvement
- Monitor, document, and report KPIs
- Provide Quality training and ensure personnel understand and adhere to Quality requirements and SOPs
- Lead and participate in process improvement initiatives
- Perform audits in the laboratory in compliance with GCP & SOP requirements
- Participate in the document development process
- Perform supplier qualification
- Host site visits/inspections/audits as requested
- Log and manage deviations, participate in the CAPA process, perform effectiveness checks
- Participate in record review, including computer system validation
- Clinical Laboratory/Animal Welfare Regulatory Compliance and Accreditation
- IACUC, IBC
- Perform Post Approval Monitoring to evaluate animal welfare and safety guidelines and regulations
- Serve as IACUC Coordinator, responsible for managing, scheduling, and documenting activities and reports
- CLIA, Joint Commission, CA DPH, MD DHMH, NY DOH, RI DOH, PA DOH
- Lead and participate in internal audits to identify areas for improvement with Clinical Laboratory regulations
- Assist with regulatory audits
- AAALAC, OLAW
- Assist in evaluating compliance with animal welfare guidelines and regulations
- Serve as point of contact, responsible for managing, scheduling, and documenting activities, site audits, and reports
- Perform administrative updates to protocols in conjunction with Principal Investigators
- Environmental, Health & Safety
- Assists with maintenance of the occupational health program
- Serve as a resource to departments to maintain a safe working environment – identifying hazards, risks, and appropriate mitigation
- Identify processes to meet Federal, state and local regulatory requirements, such as EPA, OSHA, MDE, including reporting in accordance with timelines
- Business Inquiries
- Respond to questionnaires requesting information on company processes, capabilities
- IACUC, IBC
KNOWLEDGE, SKILLS AND ABILITIES
- Knowledge and understanding of contract research organizations and animal welfare/clinical laboratory regulations.
- Demonstrated ability to work effectively and productively in a team-oriented environment.
- Creative and flexible problem solver with sound judgment, integrity, and confidentiality.
- Possess planning, organizational, computer, written and verbal communication skills.
- Ability to effectively network, negotiate, and influence.
- Demonstrated accountability and responsibility for own work.
EDUCATION AND EXPERIENCE
- BS/BA degree. Masters preferred.
- Certification through ASQ, AALAS, or similar institution preferred.
- Demonstrated comprehensive knowledge of and experience in quality assurance and process improvement.
- Experience in regulatory and compliance aspects of clinical laboratory and/or in vivo
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Must be able to sit and use hands to finger, handle and feel.
- Must be able to sit for long periods of time using a computer in a typical office environment in a multi-level facility.
- Some activities require repetitive motion and reaching, pulling or pushing.
- In carrying out the duties of the job there may be exposure to fumes, chemical hazards, or exposure to blood, body fluid, and tissue.
This job description may be changed to include new responsibilities and tasks or change existing ones as management deems necessary.