The Quality Assurance Specialist II is responsible for supporting the quality assurance needs of Certara Drug Development Solutions (CDDS); including but not limited to ensuring internal compliance to Certara's Quality Management System (QMS) and liaise with customers/clients and global regulatory agencies. This position is responsible for assisting in the delivery of global corporate quality assurance initiatives and ensuring compliance of CDDS projects/studies against applicable regulatory standards. This position will interact with world-class leading subject matter experts.

Responsibilities:

• Lead or support client audits and inspections by regulatory authorities. Execute timely follow ups on action items stemming from audit responses.
• Conduct internal and supplier (vendor) audits for compliance with Certara standard operating procedures (SOPs) and policies.
• Draft and maintain CDDS policies and SOPs, through collaboration with subject matter experts and senior management, covering but not limited to the following spectrum of activities:
  • Preclinical GLP and clinical GCP Phase 1 studies.
  • Clinical GCP Phase 2 and 3 studies.
  • Regulatory submissions.
• Assist in the rollout and implementation of corporate and/or CDDS quality initiatives.
• Assist with the validation/qualification, implementation and maintenance of QA and/or CDDS-owned computer systems.
• Work collaboratively with consulting staff to investigate, document and resolve deviations and corrective actions/preventative actions (CAPAs). Execute timely follow ups on pending action items.
• May conduct project audits including the review of study reports, associated datasets and analyses, and associated documentation for compliance with regulations and guidelines (i.e., GCP and/or GLP), scientific practices, client SOPs and expectations.
• Support the accuracy of quality metrics in applicable systems.
• Communicate all identified compliance and quality risks to management.

Qualifications:

• Bachelor of Science degree in a scientific or health-related discipline or equivalent experience (four years).
• At least five years of experience in quality assurance or quality management.
• At least one year of GCP auditing experience.
• Good understanding and experience with electronic QMS systems used to manage SOPs, CAPAs, Deviations, Audits.
• Quality certification preferred (RQAP-GLP or RQAP-GCP).
• At least one year of experience with a variety of PK/PD analysis tools and reporting tools, such as Phoenix WinNonlin, R, SAS, NONMEM, PKS, and Phoenix NLME (an asset).

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, p regnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.