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Clinical Quality Assurance Specialist II

Date:  Nov 24, 2022
Location: 

Danvers, Massachusetts, US, 01923

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

Job Description:

The Clinical Quality Assurance Specialist II is responsible for providing  guidance related to relevant and current GCP regulations and guidelines during the conduct of clinical studies. The Clinical QS is expected to assist in developing, implementing, and maintaining a clinical quality assurance program, under the direction of the Director of Quality Systems and in collaboration with the Director of Clinical Operations.

Primary Duties and Responsibilities:

  • Collaborate with Senior Clinical Quality Assurance Specialist  to provide strategic direction and advisement to clinical study management teams related to GCP risk, including the identification and  prioritization of risks and the definition of mitigation plans
  • Assist in defining  and ensuring visibility & interpretation of predictive risk indicators and quality metrics as they relate to internal process and outsourced third party activities
  • Participates in  the development of an internal clinical quality auditing program; works with Senior Clinical Quality Assurance Specialist in conducting audits of the study trial master  files, clinical investigator sites, and vendors, including CROs; writes and distributes audit reports that describe audit findings.
  • Support preparation, coordination, and management of regulatory agency inspections, including clinical site and CRO audits.
  • Coordinate and Conduct Clinical Site audits aa well as audits of CROs and other vendors.
  • Maintain contemporary knowledge of the evolving regulatory expectations and global environment that impact the business to proactively manage risks and increase the robustness of business processes and decision making
  • Collaborate or lead in the development of departmental SOPs, work instructions, template, and forms.
  • Act as a point of escalation for emergent quality issues relating to clinical trials
  • Participate on project teams as an extended team member.
  • Other duties as specified.

 

Job Qualifications:

  • Bachelor’s degree in a scientific or related discipline
  • 4 years of clinical research experience
  • Class III cardiovascular medical device experience preferred.
  • Familiarity with Quality System standards and regulations.
  • Excellent verbal and written communication skills
  • Strong organizational skills; must be detailed-oriented
  • Strong knowledge of Microsoft Office Suite and Adobe Acrobat

Ability to travel up to 25% of the time.

 

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.


Nearest Major Market: Boston