Manager, Quality Assurance, Training & Compliance

Champions Oncology

Rockville, MD, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 02/26/2021
  • Website: championsoncology.com
  • Company Address: One University Plaza Suite 307, Hackensack, NJ, 07601

About Champions Oncology

Champions Oncology, Inc. provides an end-to-end range of research and development solutions and services that improve the productivity of oncology drug development. Using both in vitro to in vivo testing platforms companies can leverage the expertise at Champions Oncology to help guide decision making for clinical development scenarios.

Job Description

Champions Oncology provides an end-to-end range of oncology research and development solutions and services that improve the productivity of drug development. As a growing Contract Research Organization (CRO), our work environment is fast-paced, challenging and ever adapting to meet the needs and timelines of our pharmaceutical-clients. Our team is passionate and self-motivated working together to accelerate the challenges of oncology drug development and ultimately improve patients’ lives around the world. 

 

Job classification and location: Full-time, Salary (exempt) in Rockville, MD.  

 

Job overview

The Quality Assurance Manager will promote and support a culture of compliance and quality with the highest legal and ethical standards throughout all business lines by interacting with all levels and departments of the organization under minimum supervision. Additional responsibilities include:

 

  • Perform or oversee all functions of the Quality Management System – training management, deviation management, complaint management, document control, equipment management, supplier management, etc.
  • Perform internal and supplier qualification audits.
  • Host external audits from regulatory bodies, standard setting organizations and clients.
  • Perform administrator functions of an electronic Quality Management System (eQMS)
  • Prepare metrics for management review
  • Identify opportunities for continuous improvement and situations of non-compliance
  • Assist and/or coordinate in the delivery of annual refresher trainings (BBP, HazComm, HIPAA, GxP, etc.)
  • Assist in the oversight of compliance areas and serve as point of contact for documenting activities, audits and reports where -applicable related to
    • Animal welfare (IACUC Coordinator/member, OLAW, AAALAC)
    • Clinical laboratory (CLIA, GCLP, multiple State Departments of Health, The Joint Commission)
    • Controlled dangerous substances (DEA, MD Department of Health and Mental Hygiene)
    • Safety (OSHA, MOSH, IBC, Safety Committee)
  • Respond to questionnaires from clients in purporting capabilities of the company
  • Other duties as assigned 

 

Qualifications and Skills

  • Education: BS/BA degree in a science-related field and 5 years of Quality Assurance experience 
  • Certification through ASQ, AALAS, or similar institution preferred.
  • Demonstrated comprehensive knowledge of-, and experience in-, quality assurance, quality control, validation and process improvement.
  • Experience in regulatory and compliance aspects of clinical laboratory and/or in vivo research.
  • Knowledge and understanding of contract research organizations (CRO), animal research industry and clinical laboratory regulations (GLP, GCP, GCLP).
  • Demonstrated ability to work effectively and productively in a customer service environment.
  • Creative and flexible problem solver with sound judgment, integrity, and confidentiality.
  • Possess superior planning, organization, computer, written and verbal communication skills.
  • Ability to effectively network, negotiate, and influence.
  • Demonstrated ability to work independently, prioritize and manage tasks of varying complexity, and manage confidential information.
  • Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Administrator functions within an electronic QMS is preferred.
  • Auditing experience or certification is preferred.

 

Physical demands and work environment 

  • Remaining in a stationary position, often standing or sitting for prolonged periods, in atypical office environment in a multi-level facility.
  • Occasional performance of tasks within laboratories which contain human and/or animal material that may be of an infectious nature.
  • Occasional performance of tasks within laboratories which contain chemicals whose safety profile may be undetermined fully.
  • Communicating with others to exchange information.
  • Repeating motions that may include the wrists, hands and/or fingers.
  • Assessing the accuracy, neatness and thoroughness of the work assigned.
  • Sedentary work that primarily involves sitting/standing.

 

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.

Champions Oncology is an Equal Opportunity/ Affirmative Action Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.